Sorbonne Université, IMProving Emergency Care FHU, Paris, France.
Emergency Department and Service Mobile d'Urgence et de Réanimation (SMUR), Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
JAMA. 2023 Dec 19;330(23):2267-2274. doi: 10.1001/jama.2023.24391.
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.
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.
Patients were randomized to undergo conservative airway strategy of intubation withholding vs routine practice.
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.
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%]).
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.
ClinicalTrials.gov Identifier: NCT04653597.
气管插管推荐用于昏迷患者和严重脑损伤患者，但在因急性中毒而意识水平降低的患者中，其使用尚不确定。
确定在急性中毒昏迷且格拉斯哥昏迷量表评分小于 9 分的患者中，保留气管插管与常规治疗相比对临床结局的影响。
设计、地点和参与者：这是一项多中心、随机试验，在法国的 20 个急诊科和 1 个重症监护病房（ICU）进行，纳入了 2021 年 5 月 16 日至 2023 年 4 月 12 日期间疑似急性中毒且格拉斯哥昏迷量表评分小于 9 分的昏迷患者，并进行了随访，直至 2023 年 5 月 12 日。
患者被随机分配至接受保留气管插管的保守气道策略或常规治疗。
主要结局是院内死亡、ICU 住院时间和住院时间的分层复合终点。关键次要结局包括因插管引起的不良事件以及 48 小时内的肺炎。
在纳入的 225 例患者（平均年龄 33 岁；38%为女性）中，116 例在干预组，109 例在对照组，插管的比例分别为 16%和 58%。没有患者在住院期间死亡。干预组在主要结局上具有显著的临床获益，赢率为 1.85（95%CI，1.33 至 2.58）。在干预组，任何不良事件的比例较低（6%比 14.7%；绝对风险差异，8.6%[95%CI，-16.6%至-0.7%]），与对照组相比，肺炎分别发生在 8（6.9%）和 16（14.7%）例患者中（绝对风险差异，-7.8%[95%CI，-15.9%至 0.3%]）。
在疑似急性中毒的昏迷患者中，保留气管插管的保守策略与院内死亡、ICU 住院时间和住院时间的复合终点的临床获益更大相关。
ClinicalTrials.gov 标识符：NCT04653597。
