<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/NCT03020914</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0648</org_study_id>
    <nct_id>NCT03020914</nct_id>
  </id_info>
  <brief_title>Effects of Audiovisual Distraction on Desaturation and Airway Intervention in OSA-patients</brief_title>
  <acronym>AVD</acronym>
  <official_title>Effects of Audiovisual Distraction Versus Standard Sedation on Desaturation and Airway Intervention in OSA-patients Undergoing Total Knee Arthroplasty Under Neuraxial Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients will be randomly assigned to either one of two groups:&#xD;
&#xD;
        1. Standard of care sedation&#xD;
&#xD;
        2. Audiovisual distraction during surgery and in the recovery room using video goggles and&#xD;
           headphones; patients can choose a movie from a preexisting library&#xD;
&#xD;
      Monitoring and anesthesia regimen will be standardized&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before consent patients will be thoroughly informed about possible risks or benefits and&#xD;
      about their possibilities to end the study at any time point or to ask for additional&#xD;
      sedation if they feel uncomfortable or anxious. After they consent, they will be randomly&#xD;
      assigned to either receive standard sedation (Group 1) or audiovisual distraction (Group 2).&#xD;
      Each group will consist of 30 patients. The randomization schedule will be created by a&#xD;
      member of the Healthcare Research Institute using SAS software, who is not otherwise involved&#xD;
      in the trial.&#xD;
&#xD;
        1. Standard of care sedation with an initial dose of midazolam in preparation for the&#xD;
           administration of the neuraxial anesthesia; propofol infusion titrated to effect.&#xD;
&#xD;
        2. Audiovisual distraction during surgery and in the recovery room using video goggles and&#xD;
           headphones; patients can choose a movie from a preexisting library; with an initial dose&#xD;
           of midazolam in preparation for the administration of the neuraxial anesthesia,&#xD;
           additional sedation with midazolam in 1 mg increments if requested by the patient or&#xD;
           deemed necessary by the anesthesia provider.&#xD;
&#xD;
      The intraoperative anesthesia regimen will be standardized:&#xD;
&#xD;
        -  All patients will be monitored according to the American Society of Anesthesiologists&#xD;
           standard, receive either a radial arterial line or non-invasive blood pressure&#xD;
           measurement according to the preferences of the anesthesia provider and O2 via nasal&#xD;
           cannula or face mask in the operation room and the recovery room.&#xD;
&#xD;
        -  ondansetron,decadron and ketorolac may be administered as per clinical judgment of the&#xD;
           attending anesthesiologist.&#xD;
&#xD;
        -  Patients in both groups will receive neuraxial anesthesia. The attending&#xD;
           anesthesiologist is free to add an ultrasound guided peripheral nerve block:&#xD;
&#xD;
             -  Neuraxial anesthesia (combined spinal-epidural, epidural or spinal) as preferred by&#xD;
                the attending anesthesiologist. Decadron may be used as in addition to the local&#xD;
                anesthetic if the anesthesia provider wishes to do so.&#xD;
&#xD;
             -  If a peripheral nerve block is performed the appropriate amount of bupivacaine will&#xD;
                be administered under ultrasound-guidance as a single shot.&#xD;
&#xD;
             -  In case an epidural catheter was placed patients will receive a patient controlled&#xD;
                epidural analgesia immediately after arrival at the recovery room for postoperative&#xD;
                pain management.&#xD;
&#xD;
        -  Opioids and other medications with sedative or respiratory depressant side effects that&#xD;
           are not specifically mentioned above should be omitted (if possible without harm for the&#xD;
           patient) Patients in the audiovisual distraction group will choose a movie, start&#xD;
           watching it in the holding area and continue watching it in the operation room as well&#xD;
           as the first 30 min in the recovery room. Audiovisual equipment will be removed for&#xD;
           transfers or at patient request.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Desaturations</measure>
    <time_frame>start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)</time_frame>
    <description>number of desaturation events (SpO2&lt; 90% for ≥ 10 sec) measured during this time frame</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Airway Interventions</measure>
    <time_frame>start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)</time_frame>
    <description>each airway intervention (defined as one of the following: jaw thrust, oropharyngeal airway, nasopharyngeal airway, mask ventilation, larynx mask or intubation) that is implemented during this time frame will be observed and documented by research staff, if it occurs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional Sedation</measure>
    <time_frame>intraoperative</time_frame>
    <description>Patient request for additional sedation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>10 minutes before recovery room discharge</time_frame>
    <description>Patient satisfaction at recovery room discharge as measured by the Heidelberg perianesthetic questionnaire, which assesses patients' peri-anaesthetic satisfaction on a four-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Scores for each question are summed for a final score, with higher total score signifying higher satisfaction and lower total score signifying lower satisfaction. The score scale has a minimum value of 0 and a maximum value of 114 (based off 3 as the highest response score for 38 individual questions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alertness Levels</measure>
    <time_frame>4 times: preoperative, intraoperative, at time of recovery room admission, 10 minutes before recovery room discharge</time_frame>
    <description>Alertness levels measured using the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S), which rates alertness on a scale of 0-5, with higher ratings representing increased alertness (e.g. '5 - Responds readily to name spoken in normal tone'). Results reflect a median score of ratings collected at 4 time points.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Obstructive Sleep Apnea (OSA)</condition>
  <arm_group>
    <arm_group_label>Audiovisual Distraction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care sedation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Audiovisual Distraction</intervention_name>
    <description>watching a movie using video glasses and headphones</description>
    <arm_group_label>Audiovisual Distraction</arm_group_label>
    <other_name>Audiovisual Aids</other_name>
    <other_name>Zeiss Cinemizer OLED Glasses</other_name>
    <other_name>HappyMed Video Glasses</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with known OSA (preexisting diagnosis of obstructive sleep apnea (OSA) or&#xD;
             patients with a STOP BANG Score of 5 or above) undergoing primary total knee&#xD;
             arthroplasty under neuraxial anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to neuraxial anesthesia or allergy to study medication&#xD;
&#xD;
          -  Patients with audiovisual impairments prohibiting them from proper use of the study&#xD;
             device:&#xD;
&#xD;
          -  Patients who are blind&#xD;
&#xD;
          -  Patients with hearing aids&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Patients with inability to communicate in English or understand the study requirements&#xD;
&#xD;
          -  Patients with prior history of claustrophobia&#xD;
&#xD;
          -  Patients with prior history of epilepsy or seizure disorder&#xD;
&#xD;
          -  Patients undergoing a revision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stavros G Memtsoudis, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>July 8, 2020</results_first_submitted>
  <results_first_submitted_qc>May 5, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 6, 2022</results_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methamphetamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>June 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03020914/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Audiovisual Distraction</title>
          <description>Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.&#xD;
Audiovisual Distraction: watching a movie using video glasses and headphones</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care Sedation</title>
          <description>Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Surgery Cancelled</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Audiovisual Distraction</title>
          <description>Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.&#xD;
Audiovisual Distraction: watching a movie using video glasses and headphones</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care Sedation</title>
          <description>Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.</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="10"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="19"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="64" spread="8.04"/>
                    <measurement group_id="B2" value="69" spread="4.70"/>
                    <measurement group_id="B3" value="66" spread="6.99"/>
                  </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="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Desaturations</title>
        <description>number of desaturation events (SpO2&lt; 90% for ≥ 10 sec) measured during this time frame</description>
        <time_frame>start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Audiovisual Distraction</title>
            <description>Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.&#xD;
Audiovisual Distraction: watching a movie using video glasses and headphones</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Sedation</title>
            <description>Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.</description>
          </group>
        </group_list>
        <measure>
          <title>Desaturations</title>
          <description>number of desaturation events (SpO2&lt; 90% for ≥ 10 sec) measured during this time frame</description>
          <units>number of desaturation events</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Airway Interventions</title>
        <description>each airway intervention (defined as one of the following: jaw thrust, oropharyngeal airway, nasopharyngeal airway, mask ventilation, larynx mask or intubation) that is implemented during this time frame will be observed and documented by research staff, if it occurs.</description>
        <time_frame>start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Audiovisual Distraction</title>
            <description>Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.&#xD;
Audiovisual Distraction: watching a movie using video glasses and headphones</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Sedation</title>
            <description>Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.</description>
          </group>
        </group_list>
        <measure>
          <title>Airway Interventions</title>
          <description>each airway intervention (defined as one of the following: jaw thrust, oropharyngeal airway, nasopharyngeal airway, mask ventilation, larynx mask or intubation) that is implemented during this time frame will be observed and documented by research staff, if it occurs.</description>
          <units>airway interventions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Additional Sedation</title>
        <description>Patient request for additional sedation</description>
        <time_frame>intraoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Audiovisual Distraction</title>
            <description>Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.&#xD;
Audiovisual Distraction: watching a movie using video glasses and headphones</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Sedation</title>
            <description>Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.</description>
          </group>
        </group_list>
        <measure>
          <title>Additional Sedation</title>
          <description>Patient request for additional sedation</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="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patient satisfaction at recovery room discharge as measured by the Heidelberg perianesthetic questionnaire, which assesses patients' peri-anaesthetic satisfaction on a four-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Scores for each question are summed for a final score, with higher total score signifying higher satisfaction and lower total score signifying lower satisfaction. The score scale has a minimum value of 0 and a maximum value of 114 (based off 3 as the highest response score for 38 individual questions).</description>
        <time_frame>10 minutes before recovery room discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Audiovisual Distraction</title>
            <description>Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.&#xD;
Audiovisual Distraction: watching a movie using video glasses and headphones</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Sedation</title>
            <description>Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient satisfaction at recovery room discharge as measured by the Heidelberg perianesthetic questionnaire, which assesses patients' peri-anaesthetic satisfaction on a four-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Scores for each question are summed for a final score, with higher total score signifying higher satisfaction and lower total score signifying lower satisfaction. The score scale has a minimum value of 0 and a maximum value of 114 (based off 3 as the highest response score for 38 individual questions).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" lower_limit="49" upper_limit="56"/>
                    <measurement group_id="O2" value="54" lower_limit="50" upper_limit="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alertness Levels</title>
        <description>Alertness levels measured using the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S), which rates alertness on a scale of 0-5, with higher ratings representing increased alertness (e.g. '5 - Responds readily to name spoken in normal tone'). Results reflect a median score of ratings collected at 4 time points.</description>
        <time_frame>4 times: preoperative, intraoperative, at time of recovery room admission, 10 minutes before recovery room discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Audiovisual Distraction</title>
            <description>Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.&#xD;
Audiovisual Distraction: watching a movie using video glasses and headphones</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Sedation</title>
            <description>Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.</description>
          </group>
        </group_list>
        <measure>
          <title>Alertness Levels</title>
          <description>Alertness levels measured using the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S), which rates alertness on a scale of 0-5, with higher ratings representing increased alertness (e.g. '5 - Responds readily to name spoken in normal tone'). Results reflect a median score of ratings collected at 4 time points.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed</time_frame>
      <desc>All-cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed</desc>
      <group_list>
        <group group_id="E1">
          <title>Audiovisual Distraction</title>
          <description>Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.&#xD;
Audiovisual Distraction: watching a movie using video glasses and headphones</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care Sedation</title>
          <description>Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Marla Sharp, MPH, MA</name_or_title>
      <organization>Hospital for Special Surgery</organization>
      <phone>646-797-8419</phone>
      <email>sharpm@hss.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/NCT03020914
org study id: 2016-0648
nct id: NCT03020914
lead sponsor: 
has dmc: No
Patients will be randomly assigned to either one of two groups:

        1. Standard of care sedation

        2. Audiovisual distraction during surgery and in the recovery room using video goggles and
           headphones; patients can choose a movie from a preexisting library

      Monitoring and anesthesia regimen will be standardized
Before consent patients will be thoroughly informed about possible risks or benefits and
      about their possibilities to end the study at any time point or to ask for additional
      sedation if they feel uncomfortable or anxious. After they consent, they will be randomly
      assigned to either receive standard sedation (Group 1) or audiovisual distraction (Group 2).
      Each group will consist of 30 patients. The randomization schedule will be created by a
      member of the Healthcare Research Institute using SAS software, who is not otherwise involved
      in the trial.

        1. Standard of care sedation with an initial dose of midazolam in preparation for the
           administration of the neuraxial anesthesia; propofol infusion titrated to effect.

        2. Audiovisual distraction during surgery and in the recovery room using video goggles and
           headphones; patients can choose a movie from a preexisting library; with an initial dose
           of midazolam in preparation for the administration of the neuraxial anesthesia,
           additional sedation with midazolam in 1 mg increments if requested by the patient or
           deemed necessary by the anesthesia provider.

      The intraoperative anesthesia regimen will be standardized:

        -  All patients will be monitored according to the American Society of Anesthesiologists
           standard, receive either a radial arterial line or non-invasive blood pressure
           measurement according to the preferences of the anesthesia provider and O2 via nasal
           cannula or face mask in the operation room and the recovery room.

        -  ondansetron,decadron and ketorolac may be administered as per clinical judgment of the
           attending anesthesiologist.

        -  Patients in both groups will receive neuraxial anesthesia. The attending
           anesthesiologist is free to add an ultrasound guided peripheral nerve block:

             -  Neuraxial anesthesia (combined spinal-epidural, epidural or spinal) as preferred by
                the attending anesthesiologist. Decadron may be used as in addition to the local
                anesthetic if the anesthesia provider wishes to do so.

             -  If a peripheral nerve block is performed the appropriate amount of bupivacaine will
                be administered under ultrasound-guidance as a single shot.

             -  In case an epidural catheter was placed patients will receive a patient controlled
                epidural analgesia immediately after arrival at the recovery room for postoperative
                pain management.

        -  Opioids and other medications with sedative or respiratory depressant side effects that
           are not specifically mentioned above should be omitted (if possible without harm for the
           patient) Patients in the audiovisual distraction group will choose a movie, start
           watching it in the holding area and continue watching it in the operation room as well
           as the first 30 min in the recovery room. Audiovisual equipment will be removed for
           transfers or at patient request.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Desaturations
time frame: start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)
description: number of desaturation events (SpO2< 90% for ≥ 10 sec) measured during this time frame
measure: Airway Interventions
time frame: start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)
description: each airway intervention (defined as one of the following: jaw thrust, oropharyngeal airway, nasopharyngeal airway, mask ventilation, larynx mask or intubation) that is implemented during this time frame will be observed and documented by research staff, if it occurs.
measure: Additional Sedation
time frame: intraoperative
description: Patient request for additional sedation
measure: Patient Satisfaction
time frame: 10 minutes before recovery room discharge
description: Patient satisfaction at recovery room discharge as measured by the Heidelberg perianesthetic questionnaire, which assesses patients' peri-anaesthetic satisfaction on a four-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Scores for each question are summed for a final score, with higher total score signifying higher satisfaction and lower total score signifying lower satisfaction. The score scale has a minimum value of 0 and a maximum value of 114 (based off 3 as the highest response score for 38 individual questions).
measure: Alertness Levels
time frame: 4 times: preoperative, intraoperative, at time of recovery room admission, 10 minutes before recovery room discharge
description: Alertness levels measured using the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S), which rates alertness on a scale of 0-5, with higher ratings representing increased alertness (e.g. '5 - Responds readily to name spoken in normal tone'). Results reflect a median score of ratings collected at 4 time points.
arm group label: Audiovisual Distraction
arm group type: Experimental
description: Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.
arm group label: Standard of care sedation
arm group type: No Intervention
description: Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.
intervention type: Device
intervention name: Audiovisual Distraction
description: watching a movie using video glasses and headphones
arm group label: Audiovisual Distraction
other name: Audiovisual Aids
other name: Zeiss Cinemizer OLED Glasses
other name: HappyMed Video Glasses
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stavros G Memtsoudis, MD, PhD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
responsible party type: Sponsor
mesh term: Sleep Apnea, Obstructive
mesh term: Methamphetamine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 