Effect of high flow nasal cannula oxygenation on incidence of hypoxia during sedated gastrointestinal endoscopy in patients with obesity: multicentre randomised controlled trial.

Methods

Multicentre, randomised, parallel group trial.

多中心、随机、平行组试验。

Three tertiary hospitals in Shanghai, China.

中国上海的三家三级医院。

1000 adult patients with obesity (body mass index ≥28) who were scheduled for gastrointestinal endoscopy.

1000名计划进行胃肠道内镜检查的成年肥胖患者（体质指数≥28）。

Participants were randomly allocated to receive regular nasal cannula oxygenation or HFNC oxygenation during a sedated procedure with propofol and low dose sufentanil.

参与者在使用丙泊酚和低剂量舒芬太尼镇静过程中，被随机分配接受常规鼻导管氧疗或高流量鼻导管氧疗。

The primary outcome was the incidenceof hypoxia (75%≤SpO2<90% for <60 s) during the procedure.

主要结果是在操作过程中低氧血症（SpO2<90%持续时间<60秒）的发生率。

Secondary outcomes included the incidences of subclinical respiratory depression (90%≤SpO2<95% for any duration) and severe hypoxia (SpO2<75% for any duration or 75%≤SPO2<90% for >60 s) during the procedure.

次要结果包括在手术过程中亚临床呼吸抑制（90%≤SpO2<95%持续任何时长）和严重低氧血症（SpO2<75%持续任何时长或75%≤SpO2<90%持续>60秒）的发生率。

Results

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.

从2021年5月6日至2023年5月26日，共有984名患者（平均年龄49.2岁；36.9%（n=363）为女性）完成了研究并进行了分析。

Compared with regular nasal cannula oxygenation, HFNC oxygenation reduced the incidenceof 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).

与常规鼻导管给氧相比，高流量鼻导管（HFNC）给氧将低氧血症的发生率从21.2%（103/487）降低到2.0%（10/497）（差异-19.14，95%置信区间-23.09至-15.36；P<0.001），亚临床呼吸抑制的发生率从36.3%（177/487）降低到5.6%（28/497）（差异-30.71，-35.40至-25.92；P<0.001），以及严重低氧血症的发生率从4.1%（20/487）降低到0%（0/497）（差异-4.11%，-6.26至-2.48；P<0.001）。

Other sedation related adverse events did not differ between the two groups.

两组在其他镇静相关不良事件方面没有差异。

Conclusions

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.

在肥胖患者中，通过高流量鼻导管氧疗进行镇静胃肠内镜检查时的氧合显著降低了低氧血症、亚临床呼吸抑制和严重低氧血症的发生率，而没有增加其他不良事件。

trial_registration

ClinicalTrials.gov NCT04500392.

ClinicalTrials.gov NCT04500392。