SiVent
Trial question
What is the role of addition of sigh breaths in trauma patients receiving mechanical ventilation?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
25.0% female
75.0% male
N = 524
524 patients (130 female, 394 male).
Inclusion criteria: adult trauma patients receiving mechanical ventilation for < 24 hours and having risk factors for developing ARDS.
Key exclusion criteria: unwillingness of treating physician to use sigh ventilation; undergoing mechanical ventilation for > 24 hours; moribund, not expected to survive > 48 hours.
Interventions
N=261 sigh plus usual care (sigh volumes producing plateau pressures of 35 cmH20 every 6 minutes plus usual care).
N=263 usual care (care provided at the discretion of the treating physician).
Primary outcome
Median ventilator-free days at day 28
18.4 days
16.1 days
18.4 days
13.8 days
9.2 days
4.6 days
0.0 days
Sigh plus usual
care
Usual
care
No significant
difference ↔
No significant difference in median ventilator-free days at day 28 (18.4 days vs. 16.1 days; AD 1.4 days, 95% CI -0.2 to 3).
Secondary outcomes
No significant difference in ICU-free days (13.7 days vs. 11.9 days; AD 0.8 days, 95% CI -0.6 to 2.3).
No significant difference in total ventilator-free days (20 days vs. 17 days; AD 1.4 days, 95% CI -0.1 to 2.9).
Borderline significant decrease in death at day 28 (11.6% vs. 17.6%; OR 0.61, 95% CI 0.37 to 1).
Safety outcomes
No significant difference in nonfatal adverse events.
Conclusion
In adult trauma patients receiving mechanical ventilation for < 24 hours and having risk factors for developing ARDS, sigh plus usual care was not superior to usual care with respect to median ventilator-free days at day 28.
Reference
Richard K Albert, Gregory J Jurkovich, John Connett et al. Sigh Ventilation in Patients With Trauma: The SiVent Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1982-1990.
Open reference URL