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. 2023 Dec 19;330(23):2267-2274.
doi: 10.1001/jama.2023.24391.

Effect of Noninvasive Airway Management of Comatose Patients With Acute Poisoning: A Randomized Clinical Trial

Yonathan Freund  1   2 , Damien Viglino  3 , Marine Cachanado  4 , Clémentine Cassard  2 , Emmanuel Montassier  5 , Bénedicte Douay  6 , Jérémy Guenezan  7 , Pierrick Le Borgne  8 , Youri Yordanov  1   9 , Armelle Severin  10 , Mélanie Roussel  11 , Matthieu Daniel  12 , Adrien Marteau  13 , Nicolas Peschanski  14   15 , Dorian Teissandier  16   17 , Richard Macrez  18 , Julia Morere  19 , Tahar Chouihed  20 , Damien Roux  21 , Frédéric Adnet  22 , Ben Bloom  23 , Anthony Chauvin  24 , Tabassome Simon  1   4
Affiliations

Effect of Noninvasive Airway Management of Comatose Patients With Acute Poisoning: A Randomized Clinical Trial

Yonathan Freund et al. JAMA. .

Abstract

Importance: Tracheal intubation is recommended for coma patients and those with severe brain injury, but its use in patients with decreased levels of consciousness from acute poisoning is uncertain.

Objective: To determine the effect of intubation withholding vs routine practice on clinical outcomes of comatose patients with acute poisoning and a Glasgow Coma Scale score less than 9.

Design, setting, and participants: This was a multicenter, randomized trial conducted in 20 emergency departments and 1 intensive care unit (ICU) that included comatose patients with suspected acute poisoning and a Glasgow Coma Scale score less than 9 in France between May 16, 2021, and April 12, 2023, and followed up until May 12, 2023.

Intervention: Patients were randomized to undergo conservative airway strategy of intubation withholding vs routine practice.

Main outcomes and measures: The primary outcome was a hierarchical composite end point of in-hospital death, length of ICU stay, and length of hospital stay. Key secondary outcomes included adverse events resulting from intubation as well as pneumonia within 48 hours.

Results: Among the 225 included patients (mean age, 33 years; 38% female), 116 were in the intervention group and 109 in the control group, with respective proportions of intubations of 16% and 58%. No patients died during the in-hospital stay. There was a significant clinical benefit for the primary end point in the intervention group, with a win ratio of 1.85 (95% CI, 1.33 to 2.58). In the intervention group, there was a lower proportion with any adverse event (6% vs 14.7%; absolute risk difference, 8.6% [95% CI, -16.6% to -0.7%]) compared with the control group, and pneumonia occurred in 8 (6.9%) and 16 (14.7%) patients, respectively (absolute risk difference, -7.8% [95% CI, -15.9% to 0.3%]).

Conclusions and relevance: Among comatose patients with suspected acute poisoning, a conservative strategy of withholding intubation was associated with a greater clinical benefit for the composite end point of in-hospital death, length of ICU stay, and length of hospital stay.

Trial registration: ClinicalTrials.gov Identifier: NCT04653597.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Simon reported personal fees from Ablative Solutions, Air Liquide, AstraZeneca, Sanofi, Servier, Novartis, and 4Living Biotech outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Recruitment, Randomization, and Analysis of Patients From the NICO Trial
The number of patients screened but not fulfilling all inclusion criteria and no exclusion criteria was not collected. NICO indicates Non-invasive Airway Management of Comatose Poisoned Emergency Patients.
Figure 2.
Figure 2.. Distribution of Wins, Ties, and Losses for Patients
The win ratio denotes the ratio of the proportion of wins to the proportion of losses. The figure shows the distribution of wins, ties, and losses for the 116 patients in the intervention group and 109 patients in the control group (12 644 pairs of patients). Win ratio = total wins/total losses = 8166/4404 = 1.85 (95% CI, 1.33-2.58). ICU indicates intensive care unit.
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