[Safety and efficacy of the adjustable monitoring filtered type-B transnasal specialized airway catheter in anesthesia for ambulatory gastrointestinal endoscopic surgery in obese patients].
Verbatim Formal Study Abstract
Objective: To evaluate the clinical safety and efficacy of the adjustable monitoring and filtering type B transnasal specialized airway catheter (hereafter referred to as the adjustable monitoring nasopharyngeal airway) during anesthesia for elective ambulatory gastrointestinal polypectomy under digestive endoscopy in obese patients. Methods: This randomized controlled trial enrolled 92 obese patients (body mass index≥28 kg/m²) scheduled for elective ambulatory gastrointestinal polypectomy under digestive endoscopy at the General Hospital of Northern Theater Command between June and December 2025. Using a random number table, we split the participants evenly into an adjustable airway group (Group R, n=46) and a standard nasal cannula group (Group C, n=46). Anesthesia was inducted and maintained with remimazolam and alfentanil. Patients in Group R were fitted with the adjustable monitoring nasopharyngeal airway for oxygen delivery and end-tidal carbon dioxide (etCO2) monitoring, and Group C received supplemental oxygen through conventional nasal cannula. The primary outcome was defined as the incidence of intraoperative hypoxemia [pulse oximetry saturation(SpO2)<90%]. Secondary outcomes were the variations in respiratory rate, heart rate and mean arterial pressure (MAP) at time points before induction (T0), upon endoscope insertion (T1), 5 minutes post-insertion (T2), at the end of surgery (T3), and 5 minutes after waking up (T4). Additional secondary outcomes included arterial partial pressure of oxygen (PaO₂) and arterial partial pressure of carbon dioxide (PaCO₂) at T2 in both groups, and partial pressure of end-tidal carbon dioxide (PetCO₂) in group R. The duration of endoscopic therapy, dosages of remimazolam and alfentanil, the frequency of hands-on airway interventions, nasal bleeding episodes, and overall physician satisfaction scores were all systematically documented. Results: The baseline demographic and clinical characteristics matched up well between the two groups (all P>0.05). The incidence of intraoperative hypoxemia was significantly lower in group R compared with group C [2.2%(1/46) vs 32.6%(15/46),χ2=14.829,P<0.001]. Patients in Group R exhibited significantly elevated SpO2 levels at T1, T2, and T3 (all P<0.05). At T2, Group R demonstrated significantly higher PaO2 and lower PaCO2 compared to Group C, their heart rates also stayed distinctly lower (P<0.05). MAP remained comparable across both cohorts at every measured interval (P>0.05). Intraoperative PetCO2 values in Group R were consistently maintained within normative physiological parameters, accompanied by continuous and stable monitoring waveforms. Compared with Group C, Group R registered a significantly lower rate of necessity for airway interventions, shorter endoscopic procedure duration and emergence time, lower remimazolam consumption, and highter physician satisfaction (all P<0.05). Conclusions: During anesthesia for elective ambulatory gastrointestinal polypectomy under gastrointestinal endoscopy in obese patients, the adjustable monitoring nasopharyngeal airway directly protects against hypoxemia by improving oxygen delivery and curtails carbon dioxide retention. Concurrently, accurate ventilation tracking helps maintain a highly stable hemodynamic profile, the clinical safety and efficacy of this airway device substantially surpass those of the conventional nasal cannula.
目的： 探讨可调监测过滤B型经鼻异型气道导管（简称可调监测型鼻咽通气道）在肥胖患者接受日间消化内镜胃肠息肉切除手术麻醉中的安全性与有效性。 方法： 随机对照试验，选取2025年6至12月在北部战区总医院择期行日间消化内镜胃肠息肉切除术的肥胖患者（体质指数≥28 kg/m²）（n=92），采用随机数字表法将患者分为可调监测型鼻咽通气道组（R组，n=46）和鼻导管组（C组，n=46）。两组都使用瑞马唑仑及阿芬太尼进行麻醉诱导与维持。R组置入可调监测型鼻咽通气道供氧并监测呼气末二氧化碳（etCO2）波形，C组采用传统鼻导管吸氧。主要结局指标为术中低氧血症（脉搏血氧饱和度<90%）发生率，次要结局指标为两组诱导前（T0）、置镜时（T1）、入镜5 min（T2）、手术结束时（T3）及苏醒5 min（T4）时的呼吸频率、心率、平均动脉压（MAP）变化情况；两组T2时动脉血氧分压（PaO2）、动脉血二氧化碳分压（PaCO2）；R组呼气末二氧化碳分压（PetCO2），其他指标为两组内镜诊疗时间、瑞马唑仑和阿芬太尼用量、气道干预情况、鼻黏膜出血率以及医师满意度。 结果： 两组患者基线资料具有可比性（均P>0.05）。R组低氧血症发生率低于C组［2.2%（1/46）比32.6%（15/46），χ2=14.829，P<0.001）。与C组比较，R组T1、T2、T3时的脉搏血氧饱和度更高；T2时PaO2更高，PaCO2及心率更低，差异均有统计学意义（均P<0.05）。两组不同时间点MAP差异无统计学意义（均P>0.05）。R组术中PetCO2在正常生理范围内波动，监测波形连续、稳定。与C组相比，R组内镜诊疗时间短，瑞马唑仑用量少，苏醒时间短，气道干预率低，医师满意度高，差异均有统计学意义（均P<0.05）。 结论： 肥胖患者进行日间消化内镜胃肠息肉切除手术麻醉期间，应用可调监测型鼻咽通气道可改善氧合，减少二氧化碳蓄积，避免低氧血症的发生，同时提供及时准确的通气监测，使血流动力学更加稳定，其临床安全性和有效性优于传统鼻导管。.