<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/NCT03026322</url>
  </required_header>
  <id_info>
    <org_study_id>IRB #161962</org_study_id>
    <nct_id>NCT03026322</nct_id>
  </id_info>
  <brief_title>Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial</brief_title>
  <acronym>PreVent</acronym>
  <official_title>Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</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>
      Complications are common during endotracheal intubation of critically ill adults. Manual&#xD;
      ventilation between induction and intubation (&quot;bag-valve-mask&quot; ventilation) has been proposed&#xD;
      as a means of preventing hypoxemia, the most common complication of intubation outside the&#xD;
      operating room. Safety and efficacy data, however, are lacking. PreVent is a randomized trial&#xD;
      comparing manual ventilation between induction and laryngoscopy to no manual ventilation&#xD;
      between induction an laryngoscopy during endotracheal intubation of critically ill adults.&#xD;
      The primary efficacy endpoint will be the lowest arterial oxygen saturation. The primary&#xD;
      safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen,&#xD;
      and highest positive end-expiratory pressure in the 24 hours after the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PreVent is a prospective, parallel-group, pragmatic, randomized trial comparing manual&#xD;
      ventilation between induction and laryngoscopy to no manual ventilation between induction an&#xD;
      laryngoscopy during endotracheal intubation of critically ill adults. The primary aim of the&#xD;
      PreVent trial is to compare the effect of manual ventilation between induction and intubation&#xD;
      versus no manual ventilation on the lowest arterial oxygen saturation experienced by&#xD;
      critically ill adults undergoing endotracheal intubation. The PreVent trial is anticipated to&#xD;
      begin enrollment in January 2017 and will enroll adults undergoing endotracheal intubation&#xD;
      with sedation and/or neuromuscular blockade in participating units. Patients will be&#xD;
      randomized 1:1 to manual ventilation versus no manual ventilation. In the manual ventilation&#xD;
      group, manual ventilation using a bag-valve-mask will be provided from the time of induction&#xD;
      until the time of endotracheal intubation, except during laryngoscopy. In the no manual&#xD;
      ventilation group, no manual ventilation will be provided between induction and endotracheal&#xD;
      intubation, except for the treatment of hypoxemia. The primary efficacy endpoint will be the&#xD;
      lowest arterial oxygen saturation during the procedure. The primary safety endpoints will be&#xD;
      the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end&#xD;
      expiratory pressure in the 24 hours after intubation. Conduct of the trial will be overseen&#xD;
      by a Data Safety Monitoring Board. An interim analysis will be performed after the enrollment&#xD;
      of 175 patients. The analysis of the trial will be conducted in accordance with a&#xD;
      pre-specified statistical analysis plan made publicly available prior to the conclusion of&#xD;
      enrollment. The initial planned enrollment of 350 patients was increased by the Data and&#xD;
      Safety Monitoring Board at the interim analysis to a final planned enrollment of 400&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">July 6, 2018</completion_date>
  <primary_completion_date type="Actual">May 6, 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lowest arterial oxygen saturation</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
    <description>The lowest arterial oxygen saturation measured by continuous pulse oximetry (SpO2) between induction and 2 minutes after completion of the airway management procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of lowest oxygen saturation less than 90%</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
    <description>Incidence of lowest oxygen saturation less than 90% in the time from induction to 2 minutes after completion of the airway management procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of lowest oxygen saturation less than 80%</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
    <description>Incidence of lowest oxygen saturation less than 80% in the time from induction to 2 minutes after completion of the airway management procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in saturation from induction to lowest oxygen saturation</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
    <description>Change in saturation from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of desaturation</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
    <description>Incidence of desaturation as defined by a decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lowest oxygen saturation in the 24 hours after intubation.</measure>
    <time_frame>24 hours after intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Highest fraction of inspired oxygen in the 24 hours after intubation.</measure>
    <time_frame>24 hours after intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Highest positive end expiratory pressure in the 24 hours after intubation.</measure>
    <time_frame>24 hours after intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.</measure>
    <time_frame>24 hours after intubation</time_frame>
    <description>Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operator-reported pulmonary aspiration</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
    <description>Visualization of oropharyngeal or gastric contents in the pharynx, larynx, or trachea between induction and completion of airway management.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New infiltrate on chest imaging in the 48 hours after intubation</measure>
    <time_frame>48 hours after intubation</time_frame>
    <description>Determination of new infiltrate will be made by two blinded experts (pulmonary/critical care attendings or fellows) with adjudication by a third expert in the case of discordant results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation &lt; 80% (composite outcome)</measure>
    <time_frame>48 hours after intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation</measure>
    <time_frame>24 hours after intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of esophageal intubation</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lowest systolic blood pressure (peri-procedural)</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
    <description>Lowest systolic blood pressure between induction and two minutes after completion of the airway management procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New systolic blood pressure &lt; 65 mmHg or new need for vasopressor</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
    <description>New systolic blood pressure &lt; 65 mmHg or new need for vasopressor between medication administration and 2 minutes following successful placement of an endotracheal tube</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac arrest within one hour of intubation</measure>
    <time_frame>One hour after intubation.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death within one hour of intubation</measure>
    <time_frame>One hour after intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cormack-Lehane grade of glottic view</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operator-assessed difficulty of intubation</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of successful intubation on the first laryngoscopy attempt</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of laryngoscopy attempts</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from induction to successful intubation</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for additional airway equipment or a second operator</measure>
    <time_frame>Induction to 2 minutes after completion of the airway management procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator-free days</measure>
    <time_frame>28 days</time_frame>
    <description>Ventilator-free days to day 28 will be defined as the number of days alive and with unassisted breathing to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing. If a patient returns to assisted breathing and subsequently achieves unassisted breathing prior to day 28, VFD will be counted from the end of the last period of assisted breathing to day 28. If the patient is receiving assisted ventilation at day 28 or dies prior to day 28, VFD will be 0. If a patient is discharged while receiving assisted ventilation, VFD will be 0. All data will be censored at the first of hospital discharge or 28 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive care unit-free days</measure>
    <time_frame>28 days</time_frame>
    <description>ICU-free days to 28 days after enrollment will be defined as the number of days alive and not admitted to an intensive care unit service after the patient's final discharge from the intensive care unit in that hospitalization before 28 days. Patients who are never discharged from the intensive care unit will receive a value of 0. Patients who die before day 28 will receive a value of 0. For patients who return to an ICU and are subsequently discharged prior to day 28, ICU-free days will be counted from the date of final ICU discharge. All data will be censored at the first of hospital discharge or 28 days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">401</enrollment>
  <condition>Respiratory Failure</condition>
  <condition>Respiratory Failure With Hypoxia</condition>
  <condition>Endotracheal Intubation</condition>
  <arm_group>
    <arm_group_label>Manual Ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy. In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Manual Ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%. For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Ventilation</intervention_name>
    <description>Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy. In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.</description>
    <arm_group_label>Manual Ventilation</arm_group_label>
    <other_name>Bag-valve-mask ventilation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Manual Ventilation</intervention_name>
    <description>Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%. For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.</description>
    <arm_group_label>No Manual Ventilation</arm_group_label>
    <other_name>Apnea</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is located in a participating unit&#xD;
&#xD;
          -  Planned procedure is endotracheal intubation&#xD;
&#xD;
          -  Planned operator is a provider expected to routinely perform endotracheal intubation&#xD;
             in the participating unit&#xD;
&#xD;
          -  Administration of sedation and/or neuromuscular blockade is planned&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Urgency of intubation precludes safe performance of study procedures&#xD;
&#xD;
          -  Operator feels a specific approach to ventilation between induction and intubation is&#xD;
             required&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#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>Matthew W Semler, MD, MSc</last_name>
    <role>Study Director</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Todd W Rice, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana State University School of Medicine</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Health System</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harborview Medical Center, University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>September 12, 2018</last_update_submitted>
  <last_update_submitted_qc>September 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Matthew Semler</investigator_full_name>
    <investigator_title>Assistant Professor, Division of Pulmonary and Critical Care Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03026322
org study id: IRB #161962
nct id: NCT03026322
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Complications are common during endotracheal intubation of critically ill adults. Manual
      ventilation between induction and intubation ("bag-valve-mask" ventilation) has been proposed
      as a means of preventing hypoxemia, the most common complication of intubation outside the
      operating room. Safety and efficacy data, however, are lacking. PreVent is a randomized trial
      comparing manual ventilation between induction and laryngoscopy to no manual ventilation
      between induction an laryngoscopy during endotracheal intubation of critically ill adults.
      The primary efficacy endpoint will be the lowest arterial oxygen saturation. The primary
      safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen,
      and highest positive end-expiratory pressure in the 24 hours after the procedure.
PreVent is a prospective, parallel-group, pragmatic, randomized trial comparing manual
      ventilation between induction and laryngoscopy to no manual ventilation between induction an
      laryngoscopy during endotracheal intubation of critically ill adults. The primary aim of the
      PreVent trial is to compare the effect of manual ventilation between induction and intubation
      versus no manual ventilation on the lowest arterial oxygen saturation experienced by
      critically ill adults undergoing endotracheal intubation. The PreVent trial is anticipated to
      begin enrollment in January 2017 and will enroll adults undergoing endotracheal intubation
      with sedation and/or neuromuscular blockade in participating units. Patients will be
      randomized 1:1 to manual ventilation versus no manual ventilation. In the manual ventilation
      group, manual ventilation using a bag-valve-mask will be provided from the time of induction
      until the time of endotracheal intubation, except during laryngoscopy. In the no manual
      ventilation group, no manual ventilation will be provided between induction and endotracheal
      intubation, except for the treatment of hypoxemia. The primary efficacy endpoint will be the
      lowest arterial oxygen saturation during the procedure. The primary safety endpoints will be
      the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end
      expiratory pressure in the 24 hours after intubation. Conduct of the trial will be overseen
      by a Data Safety Monitoring Board. An interim analysis will be performed after the enrollment
      of 175 patients. The analysis of the trial will be conducted in accordance with a
      pre-specified statistical analysis plan made publicly available prior to the conclusion of
      enrollment. The initial planned enrollment of 350 patients was increased by the Data and
      Safety Monitoring Board at the interim analysis to a final planned enrollment of 400
      patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Lowest arterial oxygen saturation
time frame: Induction to 2 minutes after completion of the airway management procedure
description: The lowest arterial oxygen saturation measured by continuous pulse oximetry (SpO2) between induction and 2 minutes after completion of the airway management procedure.
measure: Incidence of lowest oxygen saturation less than 90%
time frame: Induction to 2 minutes after completion of the airway management procedure
description: Incidence of lowest oxygen saturation less than 90% in the time from induction to 2 minutes after completion of the airway management procedure.
measure: Incidence of lowest oxygen saturation less than 80%
time frame: Induction to 2 minutes after completion of the airway management procedure
description: Incidence of lowest oxygen saturation less than 80% in the time from induction to 2 minutes after completion of the airway management procedure.
measure: Change in saturation from induction to lowest oxygen saturation
time frame: Induction to 2 minutes after completion of the airway management procedure
description: Change in saturation from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
measure: Incidence of desaturation
time frame: Induction to 2 minutes after completion of the airway management procedure
description: Incidence of desaturation as defined by a decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
measure: Lowest oxygen saturation in the 24 hours after intubation.
time frame: 24 hours after intubation
measure: Highest fraction of inspired oxygen in the 24 hours after intubation.
time frame: 24 hours after intubation
measure: Highest positive end expiratory pressure in the 24 hours after intubation.
time frame: 24 hours after intubation
measure: Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.
time frame: 24 hours after intubation
description: Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.
measure: Operator-reported pulmonary aspiration
time frame: Induction to 2 minutes after completion of the airway management procedure
description: Visualization of oropharyngeal or gastric contents in the pharynx, larynx, or trachea between induction and completion of airway management.
measure: New infiltrate on chest imaging in the 48 hours after intubation
time frame: 48 hours after intubation
description: Determination of new infiltrate will be made by two blinded experts (pulmonary/critical care attendings or fellows) with adjudication by a third expert in the case of discordant results
measure: Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation < 80% (composite outcome)
time frame: 48 hours after intubation
measure: New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation
time frame: 24 hours after intubation
measure: Incidence of esophageal intubation
time frame: Induction to 2 minutes after completion of the airway management procedure
measure: Lowest systolic blood pressure (peri-procedural)
time frame: Induction to 2 minutes after completion of the airway management procedure
description: Lowest systolic blood pressure between induction and two minutes after completion of the airway management procedure
measure: New systolic blood pressure < 65 mmHg or new need for vasopressor
time frame: Induction to 2 minutes after completion of the airway management procedure
description: New systolic blood pressure < 65 mmHg or new need for vasopressor between medication administration and 2 minutes following successful placement of an endotracheal tube
measure: Cardiac arrest within one hour of intubation
time frame: One hour after intubation.
measure: Death within one hour of intubation
time frame: One hour after intubation
measure: Cormack-Lehane grade of glottic view
time frame: Induction to 2 minutes after completion of the airway management procedure
measure: Operator-assessed difficulty of intubation
time frame: Induction to 2 minutes after completion of the airway management procedure
measure: Incidence of successful intubation on the first laryngoscopy attempt
time frame: Induction to 2 minutes after completion of the airway management procedure
measure: Number of laryngoscopy attempts
time frame: Induction to 2 minutes after completion of the airway management procedure
measure: Time from induction to successful intubation
time frame: Induction to 2 minutes after completion of the airway management procedure
measure: Need for additional airway equipment or a second operator
time frame: Induction to 2 minutes after completion of the airway management procedure
measure: In-hospital mortality
time frame: 28 days
measure: Ventilator-free days
time frame: 28 days
description: Ventilator-free days to day 28 will be defined as the number of days alive and with unassisted breathing to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing. If a patient returns to assisted breathing and subsequently achieves unassisted breathing prior to day 28, VFD will be counted from the end of the last period of assisted breathing to day 28. If the patient is receiving assisted ventilation at day 28 or dies prior to day 28, VFD will be 0. If a patient is discharged while receiving assisted ventilation, VFD will be 0. All data will be censored at the first of hospital discharge or 28 days.
measure: Intensive care unit-free days
time frame: 28 days
description: ICU-free days to 28 days after enrollment will be defined as the number of days alive and not admitted to an intensive care unit service after the patient's final discharge from the intensive care unit in that hospitalization before 28 days. Patients who are never discharged from the intensive care unit will receive a value of 0. Patients who die before day 28 will receive a value of 0. For patients who return to an ICU and are subsequently discharged prior to day 28, ICU-free days will be counted from the date of final ICU discharge. All data will be censored at the first of hospital discharge or 28 days.
arm group label: Manual Ventilation
arm group type: Active Comparator
description: Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy. In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.
arm group label: No Manual Ventilation
arm group type: Active Comparator
description: Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%. For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.
intervention type: Other
intervention name: Manual Ventilation
description: Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy. In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.
arm group label: Manual Ventilation
other name: Bag-valve-mask ventilation
intervention type: Other
intervention name: No Manual Ventilation
description: Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%. For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.
arm group label: No Manual Ventilation
other name: Apnea
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew W Semler, MD, MSc
role: Study Director
affiliation: Vanderbilt University Medical Center
last name: Todd W Rice, MD, MSc
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Matthew Semler
investigator title: Assistant Professor, Division of Pulmonary and Critical Care Medicine
mesh term: Respiratory Insufficiency
mesh term: Hypoxia