Holding off on intubation for patients in a coma with suspected acute poisoning safely got them home sooner in the NICO randomized trial.
A conservative strategy of withholding intubation had a win ratio of 1.85 (95% CI 1.33-2.58) compared with usual intubation practice for the composite primary endpoint of in-hospital death, length of intensive care unit (ICU) stay, and length of hospital stay.
The advantage was driven by length of admission and ICU care, as no deaths occurred, Yonathan Freund, MD, PhD, of Sorbonne Université in Paris, and colleagues reported in JAMA. The findings were also presented at the Critical Care Canada Forum in Toronto.
Withholding intubation during the first 4 hours of close observation slashed the proportion of patients ultimately intubated (16.4% vs 57.8%) and substantially reduced ICU admission (39.7% vs 66.1%) and adverse events from intubation as well (6.0% vs 14.7%).
“A conservative strategy can be used to avoid unnecessary intubation in comatose patients after acute poisoning and could lead to a lower risk of adverse events,” the group wrote, suggesting that the ubiquitous “less than 8, intubate” adage might need to change.
An accompanying editorial by M. Kit Delgado, MD, of the University of Pennsylvania in Philadelphia, and colleagues noted how useful the evidence will be.
“While there are some caveats, this is a practice-changing trial that will affect many prehospital, emergency medicine, and ICU physicians. The trial provides rigorous evidence to counter an ingrained dogma in clinical practice that has been overextrapolated beyond its limited evidence and narrow indications,” they wrote.
The trial included 225 adults (mean age 33 years, 38% female) with a Glasgow Coma Scale (GCS) score less than 9 who were treated for suspected acute poisoning at 20 emergency departments and one ICU in France. Enrollment was from May 16, 2021, and April 12, 2023, with follow-up until May 12, 2023.
Participants were enrolled either in the hospital or by the prehospital emergency medical system with an emergency physician present at the scene. Hospital-level randomization was unblinded.
The intervention hospitals withheld intubation except in emergencies defined by the protocol, including seizure, respiratory distress, vomiting, or shock. Controls had the intubation decision left to the discretion of the treating emergency physician. The intervention ended after 4 hours or once the patient had recovered to a GCS score greater than 8. During that time, patients were closely monitored by a nurse or a physician.
The intervention shortened median length of ICU stay by a full 24 hours (0 hours vs 24.0 hours, RR 0.39, 95% CI 0.24-0.66), and median length of hospital stay to 21.5 versus 37.0 hours (RR 0.74, 95% CI 0.53-1.03).
Among the secondary endpoints, withholding intubation actually numerically reduced risk of pneumonia by an absolute 7.8 percentage points, a 53% relative reduction, albeit not statistically significant. “This finding may fill a gap in the existing literature that was controversial and suggested that intubating patients for airway protection to limit the risk of aspiration pneumonia may in fact increase the risk of pneumonia,” the researchers noted.
The editorialists cautioned that the main advantage in reducing ICU admissions would require close monitoring by the emergency department nurses and physicians to identify markers of deterioration, “and this can be an added burden to already overworked nurses and physicians.”
They pointed to differences in the French emergency care system, in which physicians may evaluate patients in the prehospital setting. Patients they intubate are taken directly to the ICU.
Also, they added, “It should be noted that patients who met emergency intubation criteria including respiratory distress, oxygen desaturation, vomiting, or persistent shock were excluded.”
Other limitations included the potential that a Hawthorne effect may have influenced physician behavior and the decision to intubate due to the unblinded design.
“This study was also successful in the intervention group because of the underlying toxicology of the poisoning,” dominated by alcohol, benzodiazepines, and γ-hydroxybutyric acid (GHB)/γ-butyrolactone (GBL) intoxications, Delgado’s group noted. The latter two “are associated with less frequent need for ventilatory support, and GHB/GBL is noteworthy for ultra-short duration of effect, which supports a brief course of observation and supportive care rather than default to intubation.”
“In the U.S., amidst a profound polysubstance overdose crisis, naloxone reliably restores sufficient ventilatory status in patients with opioid co-intoxication,” the editorialists added. “An opportunity to evolve clinical practice to support expectant management to those with persistent depressed mental status but improved ventilation can confirm the suspected diagnosis of intoxication.”
Disclosures
The study was funded by a grant from the French Ministry of Health. The study sponsor was the Assistance Publique–Hôpitaux de Paris.
Freund disclosed no relevant relationships. A co-author reported personal fees from Ablative Solutions, Air Liquide, AstraZeneca, Sanofi, Servier, Novartis, and 4Living Biotech outside the submitted work.
Delgado reported grants from the NIH/National Institute on Drug Abuse (NIDA), the National Heart, Lung, and Blood Institute, the Patient-Centered Outcomes Research Institute (PCORI), the FDA, the AAA Foundation for Traffic Safety, the Abramson Family Foundation, and the CDC outside the submitted work. A fellow editorialist disclosed grant support from NIDA, the Substance Abuse and Mental Health Services Administration, PCORI, the FDA, and the City of Philadelphia Department of Public Health.
Primary Source
JAMA
Source Reference: Freund Y, et al “Effect of noninvasive airway management of comatose patients with acute poisoning: a randomized clinical trial” JAMA 2023; DOI: 10.1001/jama.2023.24391.
Secondary Source
JAMA
Source Reference: Qasim Z, et al “The value of not intubating comatose patients with acute poisoning” JAMA 2023; DOI: 10.1001/jama.2023.22462.
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