NCT03026322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

January 16, 2017

Last Update Submit

September 12, 2018

Conditions

Respiratory FailureRespiratory Failure With HypoxiaEndotracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • Lowest arterial oxygen saturation

    The lowest arterial oxygen saturation measured by continuous pulse oximetry (SpO2) between induction and 2 minutes after completion of the airway management procedure.

    Induction to 2 minutes after completion of the airway management procedure

Secondary Outcomes (26)

  • Incidence of lowest oxygen saturation less than 90%

    Induction to 2 minutes after completion of the airway management procedure

  • Incidence of lowest oxygen saturation less than 80%

    Induction to 2 minutes after completion of the airway management procedure

  • Change in saturation from induction to lowest oxygen saturation

    Induction to 2 minutes after completion of the airway management procedure

  • Incidence of desaturation

    Induction to 2 minutes after completion of the airway management procedure

  • Lowest oxygen saturation in the 24 hours after intubation.

    24 hours after intubation

  • +21 more secondary outcomes

Study Arms (2)

Manual Ventilation

ACTIVE COMPARATOR

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

No Manual Ventilation

ACTIVE COMPARATOR

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

Interventions

Manual VentilationOTHER

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.

Also known as: Bag-valve-mask ventilation
Manual Ventilation
No Manual VentilationOTHER

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.

Also known as: Apnea
No Manual Ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Louisiana State University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37209, United States

Location

Harborview Medical Center, University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (2)

  • Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Zouk AN, Gulati S, Heideman BE, Lester MG, Toporek AH, Bentov I, Self WH, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2019 Feb 28;380(9):811-821. doi: 10.1056/NEJMoa1812405. Epub 2019 Feb 18.

    PMID: 30779528DERIVED

  • Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Lester MG, Zouk AN, Gulati S, Stigler WS, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Manual ventilation to prevent hypoxaemia during endotracheal intubation of critically ill adults: protocol and statistical analysis plan for a multicentre randomised trial. BMJ Open. 2018 Aug 10;8(8):e022139. doi: 10.1136/bmjopen-2018-022139.

    PMID: 30099400DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

N(6)-2-(4-aminophenyl)ethyladenosine

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Matthew W Semler, MD, MSc

    Vanderbilt University Medical Center

    STUDY DIRECTOR

  • Todd W Rice, MD, MSc

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Division of Pulmonary and Critical Care Medicine

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 20, 2017

Study Start

March 15, 2017

Primary Completion

May 6, 2018

Study Completion

July 6, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations

US(5)