<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04410783</url>
  </required_header>
  <id_info>
    <org_study_id>201909100</org_study_id>
    <secondary_id>R34HL150404</secondary_id>
    <nct_id>NCT04410783</nct_id>
  </id_info>
  <brief_title>The Emergency Department Sedation Pilot Trial</brief_title>
  <acronym>ED SED Pilot</acronym>
  <official_title>The ED-SED Pilot: a Multicenter, Before-After Study to Improve Sedation in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cooper University Health Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ED-SED Pilot is a multicenter, prospective, before-and-after study conducted on 344&#xD;
      mechanically ventilated emergency department patients at three academic medical centers:&#xD;
      Washington University in St. Louis School of Medicine (St. Louis, MO), Cooper Hospital of&#xD;
      Rowan University (Camden, NJ), and University of Iowa Carver College of Medicine (Iowa City,&#xD;
      IA). The overall goal is to assess the feasibility of implementing targeted sedation (in&#xD;
      terms of sedation depth) for mechanically ventilated ED patients in order to reduce the&#xD;
      incidence of unnecessary deep sedation and improve clinical outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ED-SED Pilot is a multicenter, prospective, before-and-after study conducted on 344&#xD;
      mechanically ventilated ED patients at three academic medical centers. Patients in the before&#xD;
      phase of the study will receive usual care after the initiation of mechanical ventilation.&#xD;
      After 172 patients have been enrolled in the before phase, the investigators will begin&#xD;
      educational initiatives to implement ED-based sedation protocols and order sets. The research&#xD;
      team will educate providers on the importance of sedation protocols on patient outcome so&#xD;
      that the existing protocols begin to be used effectively in the ED. This educational&#xD;
      initiative will allow targeted sedation to be effectively used in the ED as well, allowing&#xD;
      the intervention to be tested under real-world conditions. Participants in the after phase&#xD;
      will also receive standard post-intubation care at the discretion of the treating team,&#xD;
      though it will be after the educational initiative aimed at improving post-intubation&#xD;
      sedation.&#xD;
&#xD;
      In order to more effectively use sedation in the ED, the investigators will collect voluntary&#xD;
      and anonymous surveys from ED nurses and physicians to assess the potential facilitators and&#xD;
      barriers to adherence to guideline-recommended sedation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Actual">May 28, 2022</completion_date>
  <primary_completion_date type="Actual">May 28, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a prospective, before-and-after study, and there will be no randomization process.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participant Recruitment</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Count of eligible participants included in study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range</measure>
    <time_frame>Up to 12 hours (during mechanical ventilation in the emergency department)</time_frame>
    <description>Deep sedation defined as RASS of -3 to -5&#xD;
Measure of Sedation via RASS. Scale: +4 Combative, +3 Very agitated, +2 Agitated, +1 Restless, 0 Alert and Calm, -1 Drowsy, -2 Light sedation, -3 Moderate sedation, -4 Deep sedation, -5 Unarousable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED</measure>
    <time_frame>Up to 12 hours (during mechanical ventilation in the emergency department)</time_frame>
    <description>Interrater correlation coeficient. These were paired observations between study team members and ED nurses. It reflects the degree of agreement between independent observers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>Up to 12 hours (during mechanical ventilation in the emergency department)</time_frame>
    <description>Inadvertent extubation, inadvertent device removal (e.g. central venous catheter, urinary catheter), awareness with paralysis events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ventilator-free Days</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>To define, ventilator-free days equal: 1) 0 if patient dies within 28 days of mechanical ventilation; 2) 28 - x if successfully liberated from mechanical ventilation 'x' days after intubation; or 3) 0 if mechanical ventilation duration exceeds 28 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU-free Days</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>To define, ICU-free days equal: 1) 0 if patient dies within 28 days of ICU admission; 2) 28 - x if successfully discharged from the ICU 'x' days after admission to the ICU; or 3) 0 if ICU length of stay exceeds 28 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital-free Days</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>To define, hospital-free days equal: 1) 0 if patient dies within 28 days of hospital admission; 2) 28 - x if successfully discharged from the hospital 'x' days after admission to the hospital; or 3) 0 if hospital length of stay exceeds 28 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Delirium</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Up to 28 days, or for the duration of hospitalization</time_frame>
    <description>Hospital mortality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1771</enrollment>
  <condition>Mechanical Ventilation</condition>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Before group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>After group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.</description>
    <arm_group_label>After group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard post intubation sedation practices</intervention_name>
    <description>Usual care sedation provide in the ED</description>
    <arm_group_label>Before group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Mechanical ventilation via an endotracheal tube.&#xD;
&#xD;
          2. Age ≥ 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute neurologic injury (stroke, intracranial hemorrhage, traumatic brain injury,&#xD;
             cardiac arrest, status epilepticus, fulminant hepatic failure).&#xD;
&#xD;
          2. Ongoing neuromuscular blockade.&#xD;
&#xD;
          3. Death or transition to comfort measures within 24 hours.&#xD;
&#xD;
          4. Transfer to another hospital from the ED.&#xD;
&#xD;
          5. Chronic/home mechanical ventilation.&#xD;
&#xD;
          6. Transfer directly from the ED to the operating room.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Fuller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine/Barnes-Jewish Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cooper University Hospital/Cooper Medical School of Rowan University</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <results_first_submitted>October 26, 2022</results_first_submitted>
  <results_first_submitted_qc>December 6, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 28, 2022</results_first_posted>
  <last_update_submitted>December 6, 2022</last_update_submitted>
  <last_update_submitted_qc>December 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Brian Fuller</investigator_full_name>
    <investigator_title>Associate Professor of Anesthesiology and Emergency Medicine</investigator_title>
  </responsible_party>
  <keyword>Sedation</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Emergency Department</keyword>
  <keyword>RASS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Sharing of data generated by this trial is an important part of the proposed activities. Data will be shared with other investigators through academically established means, as necessary and appropriate. Datasets generated from the trial will be available from the overall study principal investigator on reasonable request. Collaboration with others investigators is encouraged. The results will be disseminated via publication in a peer-reviewed journal and presentation at national meetings.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 3, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT04410783/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Before Group</title>
          <description>Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation&#xD;
Standard post intubation sedation practices: Usual care sedation provide in the ED</description>
        </group>
        <group group_id="P2">
          <title>After Group</title>
          <description>Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED&#xD;
Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="876"/>
                <participants group_id="P2" count="895"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="196"/>
                <participants group_id="P2" count="219"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="680"/>
                <participants group_id="P2" count="676"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Before Group</title>
          <description>Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation&#xD;
Standard post intubation sedation practices: Usual care sedation provide in the ED</description>
        </group>
        <group group_id="B2">
          <title>After Group</title>
          <description>Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED&#xD;
Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="196"/>
            <count group_id="B2" value="219"/>
            <count group_id="B3" value="415"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                    <measurement group_id="B2" value="134"/>
                    <measurement group_id="B3" value="254"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.9" spread="18.4"/>
                    <measurement group_id="B2" value="57.4" spread="18.3"/>
                    <measurement group_id="B3" value="57.6" spread="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="161"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                    <measurement group_id="B2" value="129"/>
                    <measurement group_id="B3" value="254"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="203"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="165"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="196"/>
                    <measurement group_id="B2" value="219"/>
                    <measurement group_id="B3" value="415"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Participant Recruitment</title>
        <description>Count of eligible participants included in study</description>
        <time_frame>Through study completion, an average of 1 year</time_frame>
        <population>These numbers reflect the number of eligible participants who were included in the study for analysis (i.e. the final study population). As mentioned above in &quot;Participant Flow&quot;, there were 1771 participants assessed for eligibility and 1356 were not eligible for the study. Therefore, the overall number of participants analyzed (i.e. 415) relects this.</population>
        <group_list>
          <group group_id="O1">
            <title>Before Group</title>
            <description>Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation&#xD;
Standard post intubation sedation practices: Usual care sedation provide in the ED</description>
          </group>
          <group group_id="O2">
            <title>After Group</title>
            <description>Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED&#xD;
Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Recruitment</title>
          <description>Count of eligible participants included in study</description>
          <population>These numbers reflect the number of eligible participants who were included in the study for analysis (i.e. the final study population). As mentioned above in &quot;Participant Flow&quot;, there were 1771 participants assessed for eligibility and 1356 were not eligible for the study. Therefore, the overall number of participants analyzed (i.e. 415) relects this.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="196"/>
                <count group_id="O2" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="196"/>
                    <measurement group_id="O2" value="219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range</title>
        <description>Deep sedation defined as RASS of -3 to -5&#xD;
Measure of Sedation via RASS. Scale: +4 Combative, +3 Very agitated, +2 Agitated, +1 Restless, 0 Alert and Calm, -1 Drowsy, -2 Light sedation, -3 Moderate sedation, -4 Deep sedation, -5 Unarousable</description>
        <time_frame>Up to 12 hours (during mechanical ventilation in the emergency department)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Before Group</title>
            <description>Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation&#xD;
Standard post intubation sedation practices: Usual care sedation provide in the ED</description>
          </group>
          <group group_id="O2">
            <title>After Group</title>
            <description>Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED&#xD;
Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range</title>
          <description>Deep sedation defined as RASS of -3 to -5&#xD;
Measure of Sedation via RASS. Scale: +4 Combative, +3 Very agitated, +2 Agitated, +1 Restless, 0 Alert and Calm, -1 Drowsy, -2 Light sedation, -3 Moderate sedation, -4 Deep sedation, -5 Unarousable</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="196"/>
                <count group_id="O2" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED</title>
        <description>Interrater correlation coeficient. These were paired observations between study team members and ED nurses. It reflects the degree of agreement between independent observers.</description>
        <time_frame>Up to 12 hours (during mechanical ventilation in the emergency department)</time_frame>
        <population>Reliability of RASS assessments was only assessed in the after group as an assurance that the protocol was being effectively implemented and RASS measured appropriately</population>
        <group_list>
          <group group_id="O1">
            <title>Before Group</title>
            <description>Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation&#xD;
Standard post intubation sedation practices: Usual care sedation provide in the ED</description>
          </group>
          <group group_id="O2">
            <title>After Group</title>
            <description>Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED&#xD;
Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.</description>
          </group>
        </group_list>
        <measure>
          <title>Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED</title>
          <description>Interrater correlation coeficient. These were paired observations between study team members and ED nurses. It reflects the degree of agreement between independent observers.</description>
          <population>Reliability of RASS assessments was only assessed in the after group as an assurance that the protocol was being effectively implemented and RASS measured appropriately</population>
          <units>ICC</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.88" lower_limit="0.82" upper_limit="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>Inadvertent extubation, inadvertent device removal (e.g. central venous catheter, urinary catheter), awareness with paralysis events</description>
        <time_frame>Up to 12 hours (during mechanical ventilation in the emergency department)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Before Group</title>
            <description>Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation&#xD;
Standard post intubation sedation practices: Usual care sedation provide in the ED</description>
          </group>
          <group group_id="O2">
            <title>After Group</title>
            <description>Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED&#xD;
Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>Inadvertent extubation, inadvertent device removal (e.g. central venous catheter, urinary catheter), awareness with paralysis events</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="196"/>
                <count group_id="O2" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ventilator-free Days</title>
        <description>To define, ventilator-free days equal: 1) 0 if patient dies within 28 days of mechanical ventilation; 2) 28 - x if successfully liberated from mechanical ventilation 'x' days after intubation; or 3) 0 if mechanical ventilation duration exceeds 28 days.</description>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Before Group</title>
            <description>Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation&#xD;
Standard post intubation sedation practices: Usual care sedation provide in the ED</description>
          </group>
          <group group_id="O2">
            <title>After Group</title>
            <description>Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED&#xD;
Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.</description>
          </group>
        </group_list>
        <measure>
          <title>Ventilator-free Days</title>
          <description>To define, ventilator-free days equal: 1) 0 if patient dies within 28 days of mechanical ventilation; 2) 28 - x if successfully liberated from mechanical ventilation 'x' days after intubation; or 3) 0 if mechanical ventilation duration exceeds 28 days.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="196"/>
                <count group_id="O2" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.9" spread="10.6"/>
                    <measurement group_id="O2" value="22.0" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ICU-free Days</title>
        <description>To define, ICU-free days equal: 1) 0 if patient dies within 28 days of ICU admission; 2) 28 - x if successfully discharged from the ICU 'x' days after admission to the ICU; or 3) 0 if ICU length of stay exceeds 28 days.</description>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Before Group</title>
            <description>Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation&#xD;
Standard post intubation sedation practices: Usual care sedation provide in the ED</description>
          </group>
          <group group_id="O2">
            <title>After Group</title>
            <description>Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED&#xD;
Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.</description>
          </group>
        </group_list>
        <measure>
          <title>ICU-free Days</title>
          <description>To define, ICU-free days equal: 1) 0 if patient dies within 28 days of ICU admission; 2) 28 - x if successfully discharged from the ICU 'x' days after admission to the ICU; or 3) 0 if ICU length of stay exceeds 28 days.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="196"/>
                <count group_id="O2" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" spread="10.4"/>
                    <measurement group_id="O2" value="20.8" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital-free Days</title>
        <description>To define, hospital-free days equal: 1) 0 if patient dies within 28 days of hospital admission; 2) 28 - x if successfully discharged from the hospital 'x' days after admission to the hospital; or 3) 0 if hospital length of stay exceeds 28 days.</description>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Before Group</title>
            <description>Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation&#xD;
Standard post intubation sedation practices: Usual care sedation provide in the ED</description>
          </group>
          <group group_id="O2">
            <title>After Group</title>
            <description>Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED&#xD;
Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital-free Days</title>
          <description>To define, hospital-free days equal: 1) 0 if patient dies within 28 days of hospital admission; 2) 28 - x if successfully discharged from the hospital 'x' days after admission to the hospital; or 3) 0 if hospital length of stay exceeds 28 days.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="196"/>
                <count group_id="O2" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3" spread="10.1"/>
                    <measurement group_id="O2" value="15.2" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Delirium</title>
        <description>Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care.</description>
        <time_frame>Up to 7 days</time_frame>
        <population>We recognize that the Overall Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow module. The numbers analyzed for delirium reflect the fact that some patients either died or were discharged and therefore not eligible to be assessed for delirium during the time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Before Group</title>
            <description>Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation&#xD;
Standard post intubation sedation practices: Usual care sedation provide in the ED</description>
          </group>
          <group group_id="O2">
            <title>After Group</title>
            <description>Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED&#xD;
Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Delirium</title>
          <description>Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care.</description>
          <population>We recognize that the Overall Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow module. The numbers analyzed for delirium reflect the fact that some patients either died or were discharged and therefore not eligible to be assessed for delirium during the time frame.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="167"/>
                <count group_id="O2" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mortality</title>
        <description>Hospital mortality</description>
        <time_frame>Up to 28 days, or for the duration of hospitalization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Before Group</title>
            <description>Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation&#xD;
Standard post intubation sedation practices: Usual care sedation provide in the ED</description>
          </group>
          <group group_id="O2">
            <title>After Group</title>
            <description>Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED&#xD;
Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality</title>
          <description>Hospital mortality</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="196"/>
                <count group_id="O2" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious adverse events related to care in the emergency department were collected up to 12 hours (during mechanical ventilation in the emergency department). These were reported as outcomes and include: inadvertent extubation, device removal, and awareness with paralysis. All-cause mortality was collected up to 28 days, or for the duration of hospitalization. Other (Not Including Serious) Adverse Events were collected up to 28 days, or for the duration of the hospitalization.</time_frame>
      <desc>Serious adverse events related to care in the emergency department were collected up to 12 hours (during mechanical ventilation in the emergency department). These were reported as outcomes and include inadvertent extubation, device removal, and awareness with paralysis.&#xD;
All-cause mortality was collected up to 28 days, or for the duration of hospitalization.&#xD;
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.</desc>
      <group_list>
        <group group_id="E1">
          <title>Before Group</title>
          <description>Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation&#xD;
Standard post intubation sedation practices: Usual care sedation provide in the ED</description>
        </group>
        <group group_id="E2">
          <title>After Group</title>
          <description>Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED&#xD;
Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="196"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="219"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="196"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Inadvertent extubation, device removal, awareness with paralysis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="196"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="196"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Brian M Fuller</name_or_title>
      <organization>Washington Univeristy</organization>
      <phone>3147475368</phone>
      <email>fullerb@wustl.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04410783
org study id: 201909100
secondary id: R34HL150404
nct id: NCT04410783
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The ED-SED Pilot is a multicenter, prospective, before-and-after study conducted on 344
      mechanically ventilated emergency department patients at three academic medical centers:
      Washington University in St. Louis School of Medicine (St. Louis, MO), Cooper Hospital of
      Rowan University (Camden, NJ), and University of Iowa Carver College of Medicine (Iowa City,
      IA). The overall goal is to assess the feasibility of implementing targeted sedation (in
      terms of sedation depth) for mechanically ventilated ED patients in order to reduce the
      incidence of unnecessary deep sedation and improve clinical outcomes.
The ED-SED Pilot is a multicenter, prospective, before-and-after study conducted on 344
      mechanically ventilated ED patients at three academic medical centers. Patients in the before
      phase of the study will receive usual care after the initiation of mechanical ventilation.
      After 172 patients have been enrolled in the before phase, the investigators will begin
      educational initiatives to implement ED-based sedation protocols and order sets. The research
      team will educate providers on the importance of sedation protocols on patient outcome so
      that the existing protocols begin to be used effectively in the ED. This educational
      initiative will allow targeted sedation to be effectively used in the ED as well, allowing
      the intervention to be tested under real-world conditions. Participants in the after phase
      will also receive standard post-intubation care at the discretion of the treating team,
      though it will be after the educational initiative aimed at improving post-intubation
      sedation.

      In order to more effectively use sedation in the ED, the investigators will collect voluntary
      and anonymous surveys from ED nurses and physicians to assess the potential facilitators and
      barriers to adherence to guideline-recommended sedation.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: This is a prospective, before-and-after study, and there will be no randomization process.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Participant Recruitment
time frame: Through study completion, an average of 1 year
description: Count of eligible participants included in study
measure: Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range
time frame: Up to 12 hours (during mechanical ventilation in the emergency department)
description: Deep sedation defined as RASS of -3 to -5
Measure of Sedation via RASS. Scale: +4 Combative, +3 Very agitated, +2 Agitated, +1 Restless, 0 Alert and Calm, -1 Drowsy, -2 Light sedation, -3 Moderate sedation, -4 Deep sedation, -5 Unarousable
measure: Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED
time frame: Up to 12 hours (during mechanical ventilation in the emergency department)
description: Interrater correlation coeficient. These were paired observations between study team members and ED nurses. It reflects the degree of agreement between independent observers.
measure: Number of Participants With Adverse Events
time frame: Up to 12 hours (during mechanical ventilation in the emergency department)
description: Inadvertent extubation, inadvertent device removal (e.g. central venous catheter, urinary catheter), awareness with paralysis events
measure: Ventilator-free Days
time frame: Up to 28 days
description: To define, ventilator-free days equal: 1) 0 if patient dies within 28 days of mechanical ventilation; 2) 28 - x if successfully liberated from mechanical ventilation 'x' days after intubation; or 3) 0 if mechanical ventilation duration exceeds 28 days.
measure: ICU-free Days
time frame: Up to 28 days
description: To define, ICU-free days equal: 1) 0 if patient dies within 28 days of ICU admission; 2) 28 - x if successfully discharged from the ICU 'x' days after admission to the ICU; or 3) 0 if ICU length of stay exceeds 28 days.
measure: Hospital-free Days
time frame: Up to 28 days
description: To define, hospital-free days equal: 1) 0 if patient dies within 28 days of hospital admission; 2) 28 - x if successfully discharged from the hospital 'x' days after admission to the hospital; or 3) 0 if hospital length of stay exceeds 28 days.
measure: Number of Participants With Delirium
time frame: Up to 7 days
description: Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care.
measure: Mortality
time frame: Up to 28 days, or for the duration of hospitalization
description: Hospital mortality
arm group label: Before group
arm group type: Other
description: Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation
arm group label: After group
arm group type: Other
description: Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED
intervention type: Behavioral
intervention name: Education
description: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.
arm group label: After group
intervention type: Other
intervention name: Standard post intubation sedation practices
description: Usual care sedation provide in the ED
arm group label: Before group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian Fuller, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Brian Fuller
investigator title: Associate Professor of Anesthesiology and Emergency Medicine
mesh term: Respiratory Insufficiency
mesh term: Emergencies
sharing ipd: No
ipd description: Sharing of data generated by this trial is an important part of the proposed activities. Data will be shared with other investigators through academically established means, as necessary and appropriate. Datasets generated from the trial will be available from the overall study principal investigator on reasonable request. Collaboration with others investigators is encouraged. The results will be disseminated via publication in a peer-reviewed journal and presentation at national meetings.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 