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Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial (PreVent)

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ClinicalTrials.gov Identifier: NCT03026322
Recruitment Status : Completed
First Posted : January 20, 2017
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Matthew Semler, Vanderbilt University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Respiratory Failure With Hypoxia Endotracheal Intubation Other: Manual Ventilation Other: No Manual Ventilation Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : May 6, 2018
Actual Study Completion Date : July 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: Manual Ventilation
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.
Other: Manual Ventilation
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.
Other Name: Bag-valve-mask ventilation

Active Comparator: No Manual Ventilation
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.
Other: No Manual Ventilation
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.
Other Name: Apnea




Primary Outcome Measures :
  1. Lowest arterial oxygen saturation [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
    The lowest arterial oxygen saturation measured by continuous pulse oximetry (SpO2) between induction and 2 minutes after completion of the airway management procedure.


Secondary Outcome Measures :
  1. Incidence of lowest oxygen saturation less than 90% [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
    Incidence of lowest oxygen saturation less than 90% in the time from induction to 2 minutes after completion of the airway management procedure.

  2. Incidence of lowest oxygen saturation less than 80% [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
    Incidence of lowest oxygen saturation less than 80% in the time from induction to 2 minutes after completion of the airway management procedure.

  3. Change in saturation from induction to lowest oxygen saturation [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
    Change in saturation from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.

  4. Incidence of desaturation [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
    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.

  5. Lowest oxygen saturation in the 24 hours after intubation. [ Time Frame: 24 hours after intubation ]
  6. Highest fraction of inspired oxygen in the 24 hours after intubation. [ Time Frame: 24 hours after intubation ]
  7. Highest positive end expiratory pressure in the 24 hours after intubation. [ Time Frame: 24 hours after intubation ]
  8. 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 ]
    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.

  9. Operator-reported pulmonary aspiration [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
    Visualization of oropharyngeal or gastric contents in the pharynx, larynx, or trachea between induction and completion of airway management.

  10. New infiltrate on chest imaging in the 48 hours after intubation [ Time Frame: 48 hours after intubation ]
    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

  11. Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation < 80% (composite outcome) [ Time Frame: 48 hours after intubation ]
  12. New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation [ Time Frame: 24 hours after intubation ]
  13. Incidence of esophageal intubation [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
  14. Lowest systolic blood pressure (peri-procedural) [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
    Lowest systolic blood pressure between induction and two minutes after completion of the airway management procedure

  15. New systolic blood pressure < 65 mmHg or new need for vasopressor [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
    New systolic blood pressure < 65 mmHg or new need for vasopressor between medication administration and 2 minutes following successful placement of an endotracheal tube

  16. Cardiac arrest within one hour of intubation [ Time Frame: One hour after intubation. ]
  17. Death within one hour of intubation [ Time Frame: One hour after intubation ]
  18. Cormack-Lehane grade of glottic view [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
  19. Operator-assessed difficulty of intubation [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
  20. Incidence of successful intubation on the first laryngoscopy attempt [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
  21. Number of laryngoscopy attempts [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
  22. Time from induction to successful intubation [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
  23. Need for additional airway equipment or a second operator [ Time Frame: Induction to 2 minutes after completion of the airway management procedure ]
  24. In-hospital mortality [ Time Frame: 28 days ]
  25. Ventilator-free days [ Time Frame: 28 days ]
    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.

  26. Intensive care unit-free days [ Time Frame: 28 days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is located in a participating unit
  • Planned procedure is endotracheal intubation
  • Planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
  • Administration of sedation and/or neuromuscular blockade is planned
  • Age ≥ 18 years old

Exclusion Criteria:

  • Urgency of intubation precludes safe performance of study procedures
  • Operator feels a specific approach to ventilation between induction and intubation is required
  • Pregnant women
  • Prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026322


Locations
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United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Louisiana
Louisiana State University School of Medicine
New Orleans, Louisiana, United States, 70112
Ochsner Health System
New Orleans, Louisiana, United States, 70121
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37209
United States, Washington
Harborview Medical Center, University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Study Director: Matthew W Semler, MD, MSc Vanderbilt University Medical Center
Principal Investigator: Todd W Rice, MD, MSc Vanderbilt University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthew Semler, Assistant Professor, Division of Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03026322     History of Changes
Other Study ID Numbers: IRB #161962
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms