Effect of Noninvasive Airway Management of Comatose Patients With Acute Poisoning

Abstract

ImportanceTracheal 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.ObjectiveTo 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 ParticipantsThis 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.InterventionPatients were randomized to undergo conservative airway strategy of intubation withholding vs routine practice.Main Outcomes and MeasuresThe 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.ResultsAmong 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 RelevanceAmong 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 RegistrationClinicalTrials.gov Identifier: NCT04653597

Noninvasive Airway Management of Comatose Patients With Acute Poisoning

“…3 Furthermore, assigning a GCS score involves some subjective judgment, which may lead to interobserver variability. 4 The percentage agreement for GCS scoring among physicians was not reported in this study, 1 which could lead to potential misclassification of patients in this study.…”

“…The clinical benefit reported for the primary outcome was driven by a reduced intensive care unit (ICU) admission rate and consequently shorter ICU length of stay in the intervention group. 1,2 Given that patients receiving intubation typically require ICU care, the study's design inevitably resulted in shorter ICU stays for the intervention group. This finding, therefore, does not justify avoiding intubation of intoxicated patients.…”

“…Second, the first intubation failure rates, which were significantly lower in the intervention group (5.2%) compared with the control group (22.2%), suggest a confounding factor (Table 1 and eTable 5 in the article's Supplement 3). 1 Indeed, the control group's higher failure rate may have been associated with a higher risk of pneumonia and a prolonged ICU stay. One possible explanation is that 82.5% of control group patients were intubated in prehospital or emergency settings (eTable 4 in Supplement 3).…”

“…In Reply We thank Drs Pourkarim and Entezari-Maleki for their thoughtful comment about our recent study 1 that described outcomes following metformin plus insulin for the treatment of early gestational and preexisting type 2 diabetes in pregnancy. We agree that based on available data, the use of metformin during pregnancy remains controversial and that long-term health data following in utero exposure should be collected prior to asserting that there are no unintended negative health consequences in childhood or adulthood.…”

Rethinking the paradigm of Glasgow Coma Scale directed intubation in poisoned comatose patients: insights from the NICO randomized controlled trial

“…The Non-Invasive Airway Management of Comatose Poisoned Emergency Patients (NICO) randomized controlled pragmatic clinical trial reported that withholding intubation in poisoned patients with GCS ≤ 8 was safe, and was associated with clinical improvement in a composite hierarchical endpoint of death, ICU stay, and hospital stay [5]. Notably, there were no deaths in the study.…”