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Multifunctional Oropharyngeal Airway and Hypoxemia in Sedated GI Endoscopy: A Multicenter RCT

2026年5月28日 更新者：Qianfoshan Hospital

Effect of a Novel Multifunctional Oropharyngeal Airway on Hypoxemia in Patients Undergoing Sedated Gastrointestinal Endoscopy: A Multicenter, Prospective, Randomized Controlled Trial

This multicenter, prospective, randomized controlled trial aims to evaluate whether a novel multifunctional oropharyngeal airway (MOPA) reduces the incidence of hypoxemia in 1,518 adult patients (ASA I-II, aged 18-80 years) undergoing elective sedated gastrointestinal endoscopy. Patients are randomized 1:1 to receive either the MOPA (which integrates oxygen delivery, PETCO₂ monitoring, and airway support) or conventional nasal cannula with standard mouthpiece. The primary endpoint is the incidence of hypoxemia (75% ≤ SpO₂ < 90% for <60 seconds) during the procedure. Secondary outcomes include severe hypoxemia, hypercapnia, PETCO₂ monitoring success, airway interventions, adverse events, and satisfaction scores. The study is conducted across 29 centers in China, with centralized randomization via an EDC system, blinded outcome assessment, and statistical analysis using a two-sided alpha of 0.05 (power 90%). Results are expected to provide high-level evidence for optimizing airway management during sedated endoscopy.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Study Title Effect of a Novel Multifunctional Oropharyngeal Airway on Hypoxemia in Patients Undergoing Sedated Gastrointestinal Endoscopy: A Multicenter, Prospective, Randomized Controlled Trial

Principal Investigator Dr. Wu Jianbo, Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

Participating Centers A total of 29 centers across China (including Zhejiang University First Affiliated Hospital, Hebei Medical University Second Hospital, Qilu Hospital of Shandong University, etc.)

Study Objective To evaluate whether a novel multifunctional oropharyngeal airway (MOPA) reduces the incidence of hypoxemia compared to conventional nasal cannula with standard mouthpiece in patients undergoing sedated gastrointestinal endoscopy.

Study Design Multicenter, prospective, parallel-group, randomized controlled trial.

Sample Size 1,518 patients (759 per group), accounting for a 20% dropout rate. Power: 90%, two-sided alpha: 0.05.

Participant Criteria

Inclusion: Age 18-80 years; ASA I-II; scheduled for elective sedated gastroscopy + colonoscopy; written informed consent.

Exclusion: Known respiratory disease (asthma, COPD, moderate-severe OSA, etc.); bleeding tendency or oral/nasal mucosal injury; severe cardiac/renal/hepatic dysfunction; therapeutic endoscopy (e.g., polypectomy, EMR); pregnancy; known drug allergy; emergency procedure; alcohol abuse; psychiatric illness; myasthenia gravis; participation in another trial within 3 months; refusal.

Interventions

Experimental group (MOPA): After standard sedation (fentanyl 0.05 μg/kg + propofol 1.5-2.5 mg/kg, then propofol infusion 4-12 mg/kg/h), a novel multifunctional oropharyngeal airway (integrating a bite block, oropharyngeal airway, oxygen delivery channel, and CO₂ sampling port) is inserted. Oxygen 3-4 L/min is delivered via the device, and PETCO₂ is continuously monitored through the sampling port.

Control group (conventional mouthpiece): Same sedation regimen. Patients receive oxygen 3-4 L/min via nasal cannula. PETCO₂ is monitored via nasal cannula sampling line. No oropharyngeal airway is used.

Both groups receive standardized rescue interventions for hypoxemia or ventilatory abnormalities.

Primary Endpoint Incidence of hypoxemia defined as 75% ≤ SpO₂ < 90% lasting < 60 seconds during the procedure.

Secondary Endpoints

Severe hypoxemia (SpO₂ < 75% OR 75% ≤ SpO₂ < 90% lasting ≥ 60 s)

PETCO₂ monitoring success rate (proportion with clear continuous waveform)

Detection rate of hypoventilation events (apnea ≥15-20 s; respiratory rate <8/min for ≥30 s) and early warning time before SpO₂ decline

Incidence of hypercapnia (PETCO₂ >50 mmHg or >45 mmHg for ≥30 s)

Adverse events: airway injury, regurgitation, aspiration, coughing, laryngospasm, post-procedural sore throat, hoarseness, dental/oral soft tissue injury

Airway intervention burden (jaw thrust, increased O₂ flow, procedure pause, face-mask ventilation, laryngeal mask/intubation)

Procedural efficiency (scope insertion-to-withdrawal time, number of interruptions/withdrawals due to respiratory events)

Endoscopist satisfaction (0-10 scale) and patient satisfaction (customized 0-2 per item score)

Safety Outcomes Device-related (mucosal injury, bleeding, sore throat), respiratory events (cough, laryngospasm, aspiration, need for advanced airway), systemic complications (hemodynamic instability, unplanned hospitalization/ICU), serious adverse events (refractory hypoxemia, emergency airway support, arrhythmia, myocardial ischemia, anaphylaxis, stroke).

Statistical Analysis Primary endpoint comparison using chi-square or Fisher's exact test; continuous variables using t-test or Mann-Whitney U test as appropriate. All tests two-sided, significance level α=0.05. Analysis sets: FAS, PP, SS. Missing data handled by multiple imputation where applicable.

Randomization and Blinding Centralized randomization via EDC system using stratified block randomization (block sizes 4,6,8; stratified by center). Patients are blinded to group assignment. Operators are unblinded due to device appearance. Outcome assessors and statisticians are blinded until database lock (two-stage unblinding).

Study Duration Start anticipated June 2026, completion December 2027.

Expected Publications 1-2 SCI-indexed papers reporting the primary and secondary outcomes.

研究类型

介入性

注册 (估计的)

1518

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Age 18-80 years;
  • BMI: 18-30 kg/m²;
  • ASA class I-II;
  • Scheduled to undergo elective sedated gastrointestinal endoscopy;
  • Willing to participate in this study and able to provide written informed consent.

Exclusion Criteria:

  • Diagnosed respiratory diseases, including asthma, bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, moderate or severe obstructive sleep apnea (OSA), pulmonary embolism, pulmonary edema, lung cancer, or upper respiratory tract infection, etc.;
  • Coagulation disorders, tendency for oral/nasal bleeding, mucosal injury, or space-occupying lesions;
  • Severe cardiac insufficiency (≤4 MetS);
  • Severe renal insufficiency (acute kidney injury [AKI] or chronic kidney disease [CKD] stage 4 or higher);
  • Severe hepatic insufficiency (Child-Pugh class C or worse);
  • Planned therapeutic endoscopy (e.g., polypectomy, endoscopic mucosal resection [EMR], or other therapeutic procedures);
  • Pregnancy or breastfeeding;
  • Allergy to the study drugs;
  • Emergency surgery;
  • Daily alcohol intake ≥60 grams;
  • History of psychiatric disorders: e.g., depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease;
  • Myasthenia gravis;
  • Participation in other related clinical trials within the past 3 months;
  • Refusal to participate.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Experimental group: Novel multifunctional oropharyngeal airway group
Before anesthesia, oxygen is administered via nasal cannula at 3-4 L/min, and the dedicated mouthpiece of the novel multifunctional oropharyngeal airway is inserted. After anesthesia induction and before gastroscope insertion, the anesthesiologist places the novel multifunctional oropharyngeal airway through the side of the mouthpiece and connects the oxygen supply device of the airway to deliver oxygen. The PETCO₂ sampling port of the airway is connected to the monitor to achieve continuous real-time end-tidal carbon dioxide monitoring. Insertion and fixation of the airway are completed under sedation to avoid patient discomfort.
设备：Novel Multifunctional Oropharyngeal Airway
The Novel Multifunctional Oropharyngeal Airway is an integrated airway device designed for sedated gastrointestinal endoscopy. It combines a modified mouthpiece, an oropharyngeal airway, an oxygen delivery channel, and a PETCO₂ sampling port into a single unit. The device maintains upper airway patency by preventing tongue prolapse, delivers oxygen directly to the pharynx near the glottis for more efficient oxygenation, and enables continuous real-time capnography monitoring. It is made of soft medical-grade material with anatomical curvature and depth markings to minimize mucosal injury and patient discomfort. The MOPA also reserves an interface for emergency jet ventilation if needed. It is inserted under sedation and allows the endoscope to pass smoothly through its central channel without obstruction.
无干预：Control group: Conventional mouthpiece group
Before anesthesia, oxygen is administered via nasal cannula at 3-4 L/min, and a conventional mouthpiece is inserted. The PETCO₂ sampling port of the nasal cannula is connected to the monitor to achieve continuous real-time end-tidal carbon dioxide monitoring. After anesthesia induction, the gastroscopy is completed without using an oropharyngeal airway.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of intraoperative hypoxemia (75% ≤ SpO₂ < 90%, duration < 60 seconds)
大体时间：Perioperative
Incidence of intraoperative hypoxemia (75% ≤ SpO₂ < 90%, duration < 60 seconds)
Perioperative

次要结果测量

结果测量
措施说明
大体时间
Incidence of severe hypoxemia (SpO₂ < 75% OR 75% ≤ SpO₂ < 90% lasting ≥ 60 seconds).
大体时间：Perioperative
Incidence of severe hypoxemia (SpO₂ < 75% OR 75% ≤ SpO₂ < 90% lasting ≥ 60 seconds).
Perioperative
PETCO₂ monitoring success rate
大体时间：Perioperative
proportion of participants from whom a clear, continuous PETCO₂ waveform is obtained
Perioperative
Detection rate of hypoventilation events
大体时间：Perioperative
apnea (waveform disappearance ≥ 15-20 seconds) / bradypnea (respiratory rate < 8 breaths/min lasting ≥ 30 seconds), etc.; and the proportion of early recognition before SpO₂ decline, as well as the advanced warning time (data exported from the monitor)
Perioperative
Incidence of hypercapnia
大体时间：Perioperative
PETCO₂ > 50 mmHg (or > 45 mmHg) lasting ≥ 30 seconds
Perioperative
Incidence of adverse events
大体时间：Perioperative
Record all adverse events that occur during the experiment for final analysis
Perioperative
Airway intervention burden
大体时间：Perioperative
jaw thrust/chin lift
Perioperative
Procedural efficiency
大体时间：perioperative
Number of withdrawals due to interruption caused by respiratory events
perioperative
Satisfaction: endoscopist satisfaction and patient satisfaction.
大体时间：perioperative
Note - Patient satisfaction: Each participant, in the absence of research personnel, will provide quantitative scores on predefined dimensions (pain level, foreign body sensation, comfort, quality of recovery, and overall experience). Each item is scored from 0 to 2 points, and the sum of the scores on all items will be used as the final satisfaction assessment. Endoscopist satisfaction: This is assessed using a 0-10 point scale, where 0 represents "very dissatisfied" and 10 represents "very satisfied". Based on their actual experience during the procedure, the endoscopist will select the corresponding number on the rating scale to indicate their satisfaction with the participant's cooperation and response throughout the entire procedure.
perioperative

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Qianfoshan Hospital

调查人员

  • 首席研究员：Jianbo WU, Doctoral、Shandong First medical university

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年5月7日

首先提交符合 QC 标准的

2026年5月28日

首次发布 (实际的)

2026年6月3日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月28日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • YXLL-KY-2026(086)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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