Liu Huan, Guo Peipei, Chen Lijian, Liu Xuesheng, Wu Huisheng
Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road, Hefei, 230022, Anhui Province, China.
Eur J Med Res. 2025 May 2;30(1):355. doi: 10.1186/s40001-025-02534-2.
Overweight and obese patients are at a higher risk of hypoxemia during sedated gastroscopy due to impaired respiratory function. The aim of this study was to investigate whether an anesthetic nasal mask could have a positive outcome in preventing hypoxemia in such patients compared with a conventional nasal catheter.
This prospective, randomized controlled trial enrolled 146 overweight/obese patients (BMI ≥ 25 kg/m) who underwent sedated gastroscopy from February 15, 2022, to December 31, 2022. Patients were randomly assigned (1:1) to receive oxygen via nasal masks or nasal cannulas using a computer-generated randomization sequence. The sample size was calculated based on an expected reduction in hypoxemia incidence from 40 to 15%, with a significance level of 0.05 and a power of 90%. Statisticians responsible for data analysis were blinded to group assignments. Both groups received standardized oxygen delivery with initial flow rates (5 L/min) to minimize procedural variability. The primary outcome was the incidence of hypoxemia (SpO ≤ 90%). Secondary outcomes included the incidence of severe hypoxemia, rescue airway interventions, and adverse events.
Of the 146 patients, 73 were assigned to the nasal mask group and 73 to the nasal cannula group. The incidence of hypoxemia was significantly lower in the nasal mask group (13.7%) compared with the nasal cannula group (37.0%; absolute risk reduction [ARR] = 23.3%, 95% CI 9.7-36.9%%, p = 0.002; relative risk reduction [RRR] = 63.0%). In addition, the nasal mask group required fewer rescue airway interventions, such as jaw thrusts and noninvasive ventilation. No significant differences were observed in adverse events between the two groups.
Nasal masks significantly reduce hypoxemia (with a 63% relative risk reduction) and the need for airway interventions during sedated gastroscopy in overweight/obese patients, without increasing adverse events. These findings support the use of nasal masks as an effective and safe airway management strategy for this patient population. Clinical trial registration number ChiCTR2100053388.
超重和肥胖患者在镇静胃镜检查期间因呼吸功能受损而发生低氧血症的风险更高。本研究的目的是调查与传统鼻导管相比，麻醉鼻罩在预防此类患者低氧血症方面是否能产生积极效果。
这项前瞻性随机对照试验纳入了2022年2月15日至2022年12月31日期间接受镇静胃镜检查的146例超重/肥胖患者（BMI≥25kg/m²）。患者使用计算机生成的随机序列随机分配（1:1），通过鼻罩或鼻导管吸氧。样本量是根据低氧血症发生率从40%降至15%的预期计算得出的，显著性水平为0.05，检验效能为90%。负责数据分析的统计人员对分组情况不知情。两组均接受初始流速为5L/min的标准化氧气输送，以尽量减少操作变异性。主要结局是低氧血症（SpO₂≤90%）的发生率。次要结局包括严重低氧血症的发生率、抢救气道干预措施和不良事件。
146例患者中，73例被分配到鼻罩组，73例被分配到鼻导管组。鼻罩组的低氧血症发生率（13.7%）显著低于鼻导管组（37.0%；绝对风险降低[ARR]=23.3%，95%CI 9.7-36.9%，p=0.002；相对风险降低[RRR]=63.0%）。此外，鼻罩组需要的抢救气道干预措施较少，如托下颌和无创通气。两组之间在不良事件方面未观察到显著差异。
鼻罩可显著降低超重/肥胖患者在镇静胃镜检查期间的低氧血症（相对风险降低63%）以及气道干预的需求，且不增加不良事件。这些发现支持将鼻罩作为该患者群体一种有效且安全的气道管理策略。临床试验注册号：ChiCTR2100053388。
