PreVent (tracheal intubation)
Trial question
What is the role of bag-mask ventilation among critically ill adult patients undergoing tracheal intubation?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 401
401 patients (175 female, 226 male).
Inclusion criteria: ICU adult patients undergoing tracheal intubation.
Key exclusion criteria: urgent need for intubation precluding randomization; a specific approach to ventilation between induction and intubation is required or contraindicated; pregnancy; incarceration.
Interventions
N=199 manual ventilation (bag-mask ventilation between induction and laryngoscopy).
N=202 no manual ventilation (no bag-mask ventilation; except after a failed attempt at laryngoscopy, as a treatment for hypoxemia).
Primary outcome
Median lowest oxygen saturation
96
93
96.0 percent
72.0 percent
48.0 percent
24.0 percent
0.0 percent
Manual
ventilation
No manual
ventilation
Significant
increase ▲
Significant increase in median lowest oxygen saturation (96 percent vs. 93 percent; AD 3.9 percent, 95% CI 1.4 to 6.5).
Secondary outcomes
Significant decrease in lowest oxygen saturation of < 80% (10.9% vs. 22.8%; RR 0.48, 95% CI 0.3 to 0.77).
No significant difference in death before hospital discharge (35.7% vs. 35.6%; RR 1, 95% CI 0.77 to 1.3).
Significant decrease in median oxygen saturation decline (1% vs. 5%; ARD -4.5, 95% CI -6.8 to -2.2).
Safety outcomes
No significant differences in operator-reported aspiration, new opacity on chest radiography in the 48 hours after tracheal intubation.
Significant difference in oxygen saturation of < 90% (29.5% vs. 40.1%).
Conclusion
In ICU adult patients undergoing tracheal intubation, manual ventilation was superior to no manual ventilation with respect to median lowest oxygen saturation.
Reference
Jonathan D Casey, David R Janz, Derek W Russell et al. Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2019 Feb 28;380(9):811-821.
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