https://jamanetwork.com/journals/jama/fullarticle/2812429

High Points
- Importance: Addresses the uncertain use of tracheal intubation in comatose patients with acute poisoning.
- Objective: To evaluate the impact of withholding intubation versus routine practice on clinical outcomes in comatose patients with acute poisoning (GCS score < 9).
- Design: A multicenter, randomized trial in France (20 EDs, 1 ICU), conducted from May 2021 to April 2023.
- Intervention: Patients were randomized to either a conservative airway strategy of withholding intubation or routine practice.
- Main Outcomes: The primary outcome was a hierarchical composite endpoint of in-hospital death, ICU stay length, and hospital stay length. Key secondary outcomes included intubation-related adverse events and pneumonia within 48 hours.
- Results: The study included 225 patients, with significant clinical benefits observed in the intervention group for the primary endpoint and reduced adverse events and pneumonia.
Key Takeaways
- Clinical Benefit: A conservative strategy of withholding intubation was associated with better outcomes in terms of in-hospital death, ICU stay, and hospital stay lengths.
- Context of Acute Poisoning: Acute poisoning is a common reason for decreased consciousness and often leads to a high rate of intubation.
- Debate on Intubation Decision: The decision to intubate in acute poisoning cases is controversial, with prior studies showing mixed results regarding the risk of aspiration and death.
- NICO Trial Focus: Aimed to improve outcomes in coma due to acute poisoning by testing a strategy of withholding intubation.
Strengths
- Robust Trial Design: The study was a multicenter, unblinded, randomized parallel-group trial, adhering to ethical standards and monitored independently.
- Patient Population and Trial Sites: Conducted across multiple sites with a well-defined patient population and inclusion/exclusion criteria.
- Randomization and Intervention: Utilized a structured randomization and intervention process, with clear criteria for emergency intubation.