Efficacy of a nasal mask oxygen kit versus regular nasal cannula in sedated gastrointestinal endoscopy: a multicentre, randomised clinical trial.

Abstract

Objective: The incidence of hypoxia in painless gastrointestinal endoscopy is not negligible. A nasal mask oxygen kit may reduce the incidence of hypoxia compared with a regular nasal cannula.

Methods: This multi-centre, randomised, open-label clinical trial took place from 1 September 2022 to 6 June 2023 in three Chinese teaching hospitals. Participants were randomly assigned 1:1 to either the intervention or the control group. Before induction of anaesthesia, a nasal cannula was used in the control group, and a nasal mask oxygen kit was used in the intervention group. The primary outcome was hypoxia (peripheral capillary oxygen saturation (SpO₂) ≥75% but <90% for <60 s). Secondary outcomes were subclinical respiratory depression (SpO₂≥90% but <95%), severe hypoxia (SpO₂<75% or SpO₂≥75% but <90% for ≥60 s) and other adverse events.

Results: Among the 1204 initially enrolled patients, 1197 completed the study, with 597 randomised to the nasal mask oxygen kit group and 600 to the control group. Compared with the control group, the nasal mask oxygen kit significantly reduced the incidence of hypoxia during gastrointestinal endoscopy under sedation (12.5% vs 7.4%; rate difference (RD) = 0.051; 95% CI 0.018 to 0.085; p=0.003), subclinical respiratory depression (13% vs 9.4%; RD = 0.036; 95% CI 0.0005 to 0.072; p=0.047) and total adverse events (27.5% vs 18.6%; RD = 0.089; 95% CI 0.042 to 0.137; p<0.001). There was no difference in the incidence of severe hypoxia (1.17% vs 0.7%; RD = 0.005; 95% CI -0.006 to 0.016; p>0.05).

Conclusions: The nasal mask oxygen kit can decrease the incidence of hypoxia in patients with American Society of Anesthesiologists class I/II undergoing gastrointestinal endoscopy under propofol and fentanyl sedation.

Trial registration number: NCT05405530.