Wang Leilei, Zhang Yuanyuan, Han Dan, Wei Mengyun, Zhang Jie, Cheng Xiangyang, Zhang Yizhe, Shi Muyan, Song Zijian, Wang Xiangrui, Zhang Xiaoqing, Su Diansan
Department of Anesthesiology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Department of Anesthesiology, East Hospital, Tongji University School of Medicine, Shanghai, China.
BMJ. 2025 Feb 11;388:e080795. doi: 10.1136/bmj-2024-080795.
To determine whether high flow nasal cannula (HFNC) oxygenation can reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in patients with obesity.
Multicentre, randomised, parallel group trial.
Three tertiary hospitals in Shanghai, China.
1000 adult patients with obesity (body mass index ≥28) who were scheduled for gastrointestinal endoscopy.
Participants were randomly allocated to receive regular nasal cannula oxygenation or HFNC oxygenation during a sedated procedure with propofol and low dose sufentanil.
The primary outcome was the incidence of hypoxia (75%≤SpO<90% for <60 s) during the procedure. Secondary outcomes included the incidences of subclinical respiratory depression (90%≤SpO<95% for any duration) and severe hypoxia (SpO<75% for any duration or 75%≤SPO<90% for >60 s) during the procedure.
From 6 May 2021 to 26 May 2023, 984 patients (mean age 49.2 years; 36.9% (n=363) female) completed the study and were analysed. Compared with regular nasal cannula oxygenation, HFNC oxygenation reduced the incidence of hypoxia from 21.2% (103/487) to 2.0% (10/497) (difference -19.14, 95% confidence interval -23.09 to -15.36; P<0.001), subclinical respiratory depression from 36.3% (177/487) to 5.6% (28/497) (difference -30.71, -35.40 to -25.92; P<0.001), and severe hypoxia from 4.1% (20/487) to 0% (0/497) (difference -4.11%, -6.26 to -2.48; P<0.001). Other sedation related adverse events did not differ between the two groups.
In patients with obesity, oxygenation via HFNC during sedated gastrointestinal endoscopy significantly reduced the incidences of hypoxia, subclinical respiratory depression, and severe hypoxia without increasing other adverse events.
ClinicalTrials.gov NCT04500392.
确定高流量鼻导管(HFNC)给氧能否降低肥胖患者镇静状态下胃肠镜检查期间缺氧的发生率。
多中心、随机、平行组试验。
中国上海的三家三级医院。
1000例计划进行胃肠镜检查的成年肥胖患者(体重指数≥28)。
参与者在使用丙泊酚和低剂量舒芬太尼的镇静操作过程中被随机分配接受常规鼻导管给氧或HFNC给氧。
主要观察指标是操作过程中缺氧(SpO₂<90%持续<60秒且75%≤SpO₂)的发生率。次要观察指标包括操作过程中亚临床呼吸抑制(SpO₂<95%持续任何时间且90%≤SpO₂)和严重缺氧(SpO₂<75%持续任何时间或SpO₂<90%持续>60秒且75%≤SpO₂)的发生率。
2021年5月6日至2023年5月26日,984例患者(平均年龄49.2岁;36.9%(n = 363)为女性)完成研究并纳入分析。与常规鼻导管给氧相比,HFNC给氧使缺氧发生率从21.2%(103/487)降至2.0%(10/497)(差值-19.14,95%置信区间-23.09至-15.36;P<0.001),亚临床呼吸抑制发生率从36.3%(177/487)降至5.6%(28/497)(差值-30.71,-35.40至-25.92;P<0.001),严重缺氧发生率从4.1%(20/487)降至0%(0/497)(差值-4.11%,-6.26至-2.48;P<0.001)。两组之间其他与镇静相关的不良事件无差异。
对于肥胖患者,在镇静状态下胃肠镜检查期间通过HFNC给氧可显著降低缺氧、亚临床呼吸抑制和严重缺氧的发生率,且不增加其他不良事件。
ClinicalTrials.gov NCT04500392