NIVAS
Trial question
What is the effect of noninvasive ventilation on tracheal intubation in patients with hypoxemic respiratory failure following abdominal surgery?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
24.0% female
76.0% male
N = 293
293 patients (69 female, 224 male).
Inclusion criteria: patients with hypoxemic respiratory failure after abdominal surgery.
Key exclusion criteria: withholding of life-sustaining treatment, contraindications to noninvasive ventilation, sleep apnea syndrome, immediate tracheal intubation, requirement for an emergent surgical procedure, and previous recruitment in another trial.
Interventions
N=148 noninvasive ventilation (delivered via facial mask, with inspiratory pressure support level, 5-15 cmH₂O; PEEP, 5-10 cmH₂O; FiO2 titrated to maintain SpO2 ≥94%).
N=145 standard oxygen therapy (up to 15 L/min to maintain SpO2 of ≥ 94%).
Primary outcome
Rate of tracheal reintubation within 7 days, in the intention-to-treat analysis
33.1%
45.5%
45.5 %
34.1 %
22.8 %
11.4 %
0.0 %
Noninvasive
ventilation
Standard oxygen
therapy
Significant
decrease ▼
NNT = 8
Significant decrease in the rate of tracheal reintubation within 7 days, in the intention-to-treat analysis (33.1% vs. 45.5%; AD -12.4%, 95% CI -23.5 to -1.3).
Secondary outcomes
No significant difference in invasive ventilation-free days at day 30 (25.4 days vs. 23.2 days; AD -2.2 days, 95% CI -0.1 to 4.6).
Safety outcomes
Significant differences in health-care associated infections (31.4% vs. 49.2%, p = 0.003; ADR, -17.8%, 95% CI -30.2% to -5.4%).
Conclusion
In patients with hypoxemic respiratory failure after abdominal surgery, noninvasive ventilation was superior to standard oxygen therapy with respect to the rate of tracheal reintubation within 7 days, in the intention-to-treat analysis.
Reference
Jaber S, Lescot T, Futier E et al. Effect of Noninvasive Ventilation on Tracheal Reintubation Among Patients With Hypoxemic Respiratory Failure Following Abdominal Surgery: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1345-53.
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