NICO
Trial question
What is the effect of restricted intubation in comatose patients with suspected acute poisoning?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 225
225 patients (85 female, 140 male).
Inclusion criteria: comatose patients with suspected acute poisoning and a GCS score < 9.
Key exclusion criteria: pregnancy; incarceration; immediate need for tracheal intubation; suspicion of cardiotropic drug poisoning; intoxication with a single toxic substance that could be reversed.
Interventions
N=116 restricted intubation (conservative airway strategy of intubation withholding).
N=109 routine practice (the decision of intubation left to the physician's discretion).
Primary outcome
Median length of mechanical ventilation
0 hours
6 hours
-1.5 hours
-3.0 hours
-4.5 hours
-6.0 hours
Restricted
intubation
Routine
practice
Significant
decrease ▼
Significant decrease in median length of mechanical ventilation (0 hours vs. 6 hours; RR 0.21, 95% CI 0.11 to 0.38).
Secondary outcomes
No significant difference in occurrence of pneumonia (6.9% vs. 14.7%; OR 0.43, 95% CI 0.18 to 1.05).
Significant decrease in first pass failure (0.9% vs. 13.1%; OR 0.06, 95% CI 0.01 to 0.46).
Safety outcomes
Significant difference in adverse event from intubation (6.0% vs. 14.7%).
Conclusion
In comatose patients with suspected acute poisoning and a GCS score < 9, restricted intubation was superior to routine practice with respect to median length of mechanical ventilation.
Reference
Yonathan Freund, Damien Viglino, Marine Cachanado et al. Effect of Noninvasive Airway Management of Comatose Patients With Acute Poisoning: A Randomized Clinical Trial. JAMA. 2023 Dec 19;330(23):2267-2274.
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