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

Respiratory Failure Clinical Trial

— PreVent  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026322
• Other study ID #: IRB #161962
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: July 6, 2018

Study information

• Verified date: September 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: July 6, 2018
• Est. primary completion date: May 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endotracheal Intubation
• Hypoxia
• Respiratory Failure
• Respiratory Failure With Hypoxia
• Respiratory Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Louisiana State University School of Medicine	New Orleans	Louisiana
United States	Ochsner Health System	New Orleans	Louisiana
United States	Harborview Medical Center, University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of lowest oxygen saturation less than 90%	Incidence of lowest oxygen saturation less than 90% in the time from induction to 2 minutes after completion of the airway management procedure.	Induction to 2 minutes after completion of the airway management procedure
Secondary	Incidence of lowest oxygen saturation less than 80%	Incidence of lowest oxygen saturation less than 80% in the time from induction to 2 minutes after completion of the airway management procedure.	Induction to 2 minutes after completion of the airway management procedure
Secondary	Change in saturation from induction to lowest oxygen saturation	Change in saturation from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.	Induction to 2 minutes after completion of the airway management procedure
Secondary	Incidence of desaturation	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.	Induction to 2 minutes after completion of the airway management procedure
Secondary	Lowest oxygen saturation in the 24 hours after intubation.		24 hours after intubation
Secondary	Highest fraction of inspired oxygen in the 24 hours after intubation.		24 hours after intubation
Secondary	Highest positive end expiratory pressure in the 24 hours after intubation.		24 hours after intubation
Secondary	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.	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.	24 hours after intubation
Secondary	Operator-reported pulmonary aspiration	Visualization of oropharyngeal or gastric contents in the pharynx, larynx, or trachea between induction and completion of airway management.	Induction to 2 minutes after completion of the airway management procedure
Secondary	New infiltrate on chest imaging in the 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	48 hours after intubation
Secondary	Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation < 80% (composite outcome)		48 hours after intubation
Secondary	New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation		24 hours after intubation
Secondary	Incidence of esophageal intubation		Induction to 2 minutes after completion of the airway management procedure
Secondary	Lowest systolic blood pressure (peri-procedural)	Lowest systolic blood pressure between induction and two minutes after completion of the airway management procedure	Induction to 2 minutes after completion of the airway management procedure
Secondary	New systolic blood pressure < 65 mmHg or new need for vasopressor	New systolic blood pressure < 65 mmHg or new need for vasopressor between medication administration and 2 minutes following successful placement of an endotracheal tube	Induction to 2 minutes after completion of the airway management procedure
Secondary	Cardiac arrest within one hour of intubation		One hour after intubation.
Secondary	Death within one hour of intubation		One hour after intubation
Secondary	Cormack-Lehane grade of glottic view		Induction to 2 minutes after completion of the airway management procedure
Secondary	Operator-assessed difficulty of intubation		Induction to 2 minutes after completion of the airway management procedure
Secondary	Incidence of successful intubation on the first laryngoscopy attempt		Induction to 2 minutes after completion of the airway management procedure
Secondary	Number of laryngoscopy attempts		Induction to 2 minutes after completion of the airway management procedure
Secondary	Time from induction to successful intubation		Induction to 2 minutes after completion of the airway management procedure
Secondary	Need for additional airway equipment or a second operator		Induction to 2 minutes after completion of the airway management procedure
Secondary	In-hospital mortality		28 days
Secondary	Ventilator-free 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.	28 days
Secondary	Intensive care unit-free 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.	28 days