Multifunctional Oropharyngeal Airway and Hypoxemia in Sedated GI Endoscopy: A Multicenter RCT
Effect of a Novel Multifunctional Oropharyngeal Airway on Hypoxemia in Patients Undergoing Sedated Gastrointestinal Endoscopy: A Multicenter, Prospective, Randomized Controlled Trial
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：jianbo wu
- 電話番号：18560083793
- メール：jianbowu@sdu.edu.cn
研究連絡先のバックアップ
- 名前：琦 尤
- 電話番号：19553100910
- メール：312011097@qq.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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.
|
|
介入なし：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of intraoperative hypoxemia (75% ≤ SpO₂ < 90%, duration < 60 seconds)
時間枠：Perioperative
|
Incidence of intraoperative hypoxemia (75% ≤ SpO₂ < 90%, duration < 60 seconds)
|
Perioperative
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of severe hypoxemia (SpO₂ < 75% OR 75% ≤ SpO₂ < 90% lasting ≥ 60 seconds).
時間枠：Perioperative
|
Incidence of severe hypoxemia (SpO₂ < 75% OR 75% ≤ SpO₂ < 90% lasting ≥ 60 seconds).
|
Perioperative
|
|
PETCO₂ monitoring success rate
時間枠：Perioperative
|
proportion of participants from whom a clear, continuous PETCO₂ waveform is obtained
|
Perioperative
|
|
Detection rate of hypoventilation events
時間枠：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
時間枠：Perioperative
|
PETCO₂ > 50 mmHg (or > 45 mmHg) lasting ≥ 30 seconds
|
Perioperative
|
|
Incidence of adverse events
時間枠：Perioperative
|
Record all adverse events that occur during the experiment for final analysis
|
Perioperative
|
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Airway intervention burden
時間枠：Perioperative
|
jaw thrust/chin lift
|
Perioperative
|
|
Procedural efficiency
時間枠：perioperative
|
Number of withdrawals due to interruption caused by respiratory events
|
perioperative
|
|
Satisfaction: endoscopist satisfaction and patient satisfaction.
時間枠：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.
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perioperative
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Jianbo Wu, Doctoral、Shandong First Medical University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- YXLL-KY-2026(086)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
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