Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.
Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.
JAMA. 2021 Dec 28;326(24):2488-2497. doi: 10.1001/jama.2021.22002.
For critically ill adults undergoing emergency tracheal intubation, failure to intubate the trachea on the first attempt occurs in up to 20% of cases and is associated with severe hypoxemia and cardiac arrest. Whether using a tracheal tube introducer ("bougie") increases the likelihood of successful intubation compared with using an endotracheal tube with stylet remains uncertain.
To determine the effect of use of a bougie vs an endotracheal tube with stylet on successful intubation on the first attempt.
DESIGN, SETTING, AND PARTICIPANTS: The Bougie or Stylet in Patients Undergoing Intubation Emergently (BOUGIE) trial was a multicenter, randomized clinical trial among 1102 critically ill adults undergoing tracheal intubation in 7 emergency departments and 8 intensive care units in the US between April 29, 2019, and February 14, 2021; the date of final follow-up was March 14, 2021.
Patients were randomly assigned to use of a bougie (n = 556) or use of an endotracheal tube with stylet (n = 546).
The primary outcome was successful intubation on the first attempt. The secondary outcome was the incidence of severe hypoxemia, defined as a peripheral oxygen saturation less than 80%.
Among 1106 patients randomized, 1102 (99.6%) completed the trial and were included in the primary analysis (median age, 58 years; 41.0% women). Successful intubation on the first attempt occurred in 447 patients (80.4%) in the bougie group and 453 patients (83.0%) in the stylet group (absolute risk difference, -2.6 percentage points [95% CI, -7.3 to 2.2]; P = .27). A total of 58 patients (11.0%) in the bougie group experienced severe hypoxemia, compared with 46 patients (8.8%) in the stylet group (absolute risk difference, 2.2 percentage points [95% CI, -1.6 to 6.0]). Esophageal intubation occurred in 4 patients (0.7%) in the bougie group and 5 patients (0.9%) in the stylet group, pneumothorax was present after intubation in 14 patients (2.5%) in the bougie group and 15 patients (2.7%) in the stylet group, and injury to oral, glottic, or thoracic structures occurred in 0 patients in the bougie group and 3 patients (0.5%) in the stylet group.
Among critically ill adults undergoing tracheal intubation, use of a bougie did not significantly increase the incidence of successful intubation on the first attempt compared with use of an endotracheal tube with stylet.
ClinicalTrials.gov Identifier: NCT03928925
对于接受紧急气管插管的危重症成人，首次尝试插管失败的发生率高达 20%，并与严重低氧血症和心脏骤停有关。与使用带管芯的气管内导管（“管芯”）相比，使用气管导管导丝是否能增加插管成功的可能性仍不确定。
确定使用管芯与使用带管芯的气管内导管在首次尝试时插管成功的效果。
设计、地点和参与者：气管插管紧急患者使用管芯或管芯（BOUGIE）试验是一项多中心、随机临床试验，纳入了 2019 年 4 月 29 日至 2021 年 2 月 14 日期间美国 7 家急诊室和 8 家重症监护病房的 1102 名接受气管插管的危重症成人；最终随访日期为 2021 年 3 月 14 日。
患者被随机分配使用管芯（n=556）或使用带管芯的气管内导管（n=546）。
主要结局是首次尝试插管成功。次要结局是严重低氧血症的发生率，定义为外周血氧饱和度低于 80%。
在随机分配的 1106 名患者中，1102 名（99.6%）完成了试验并纳入了主要分析（中位数年龄为 58 岁；41.0%为女性）。管芯组首次尝试插管成功的患者有 447 例（80.4%），管芯组有 453 例（83.0%）（绝对风险差异，-2.6 个百分点[95%CI，-7.3 至 2.2]；P=0.27）。管芯组有 58 例（11.0%）患者发生严重低氧血症，而管芯组有 46 例（8.8%）患者发生严重低氧血症（绝对风险差异，2.2 个百分点[95%CI，-1.6 至 6.0]）。管芯组有 4 例（0.7%）患者发生食管插管，管芯组有 5 例（0.9%）患者发生气胸，管芯组有 14 例（2.5%）患者在插管后发生气胸，管芯组有 0 例患者发生口腔、声门或胸部结构损伤，管芯组有 3 例（0.5%）患者发生口腔、声门或胸部结构损伤。
在接受气管插管的危重症成人中，与使用带管芯的气管内导管相比，使用管芯并未显著增加首次尝试插管成功的发生率。
ClinicalTrials.gov 标识符：NCT03928925
