Evidence map›Paper›PMID 41390738›Full record

ArticleTrials2025

Efficacy and safety of the COMBO endoscopy oropharyngeal airway in gastrointestinal endoscopy: a study protocol for a multicenter randomized controlled trial.

Yuhan Zhang, Muyan Shi, Yifeng Qu, Xiangyang Cheng, Jie Zhang, Shaohui Guo, Yueying Zheng, Diansan Su

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06081647 (The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway Reduce the Incidence of Hypoxia in Patients Undergoing Gastrointestinal Endoscopy Sedated With Propofol.), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06081647 narecruitingnot on this map

The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway Reduce the Incidence of Hypoxia in Patients Undergoing Gastrointestinal Endoscopy Sedated With Propofol.

TypeinterventionalSponsorRenJi HospitalRan2023 to 2025Enrolled1,200ConditionsHypoxia, Gastric Polyp, Colon Cancer, Esophageal CancerArmsthe COMBO Endoscopy Oropharyngeal Airway, Regular Nasal Cannula
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Yuhan Zhang *Department of Anesthesiology, School of Medicine, Renji Hospital, Shanghai Jiaotong University, Shanghai, China.
Muyan Shi *Department of Anesthesiology, School of Medicine, Renji Hospital, Shanghai Jiaotong University, Shanghai, China.
Yifeng Qu *Department of Anesthesiology, School of Medicine, Renji Hospital, Shanghai Jiaotong University, Shanghai, China.
Xiangyang ChengDepartment of Anesthesiology, School of Medicine, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.
Jie ZhangDepartment of Anesthesiology, School of Medicine, Renji Hospital, Shanghai Jiaotong University, Shanghai, China.
Shaohui GuoDepartment of Anesthesiology, School of Medicine, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.
Yueying ZhengDepartment of Anesthesiology, School of Medicine, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.
Diansan SuDepartment of Anesthesiology, School of Medicine, The First Affiliated Hospital, Zhejiang University, Hangzhou, China. diansansu@zju.edu.cn.ORCID http://orcid.org/0000-0001-9755-1025

Funding

National Natural Science Foundation of China U21A20357
6 · The paper itself

Abstract

backgroundHypoxia is one of the most common adverse events of sedated gastrointestinal (GI) endoscopy. It can cause coronary ischemia and permanent nervous system damage, potentially leading to death if not promptly addressed. This study aims to examine the efficacy and safety of the COMBO (capnography monitoring bite block oxygenation) endoscopy oropharyngeal airway in patients undergoing sedated GI endoscopy.

methodsA multicenter randomized, open-label, two-arm parallel-group superiority clinical trial with an active comparator will be conducted to evaluate the impact of the COMBO endoscopy oropharyngeal airway on the incidence of hypoxia. This study will include patients (n = 1200) undergoing GI endoscopy under propofol sedation. Written informed consent will be obtained from them. The participants (patients undergoing elective upper gastrointestinal endoscopic surgery, ≥ 18 years old and ≤ 60 years old, American Society of Anesthesiologists Grade I-II, expected inspection time ≤ 45 min) will be randomly assigned to a conventional nasal cannula (Arm 1)or the COMBO endoscopy oropharyngeal airway group (Arm 2). The intervention group will be administered the COMBO endoscopy oropharyngeal airway correspondingly. The primary objective is the incidence of hypoxia (75% ≤ SpO DISCUSSION: The COMBO endoscopy oropharyngeal airway is a novel method for oxygenation and airway management. This study is aimed at investigating whether the COMBO endoscopy oropharyngeal airway can reduce the incidence of hypoxia in patients during gastrointestinal endoscopy under sedation with propofol. If successful, our proposal could play a pivotal role that represents a significant advancement in airway management in preventing hypoxemia during GI endoscopy under propofol sedation.

trial registrationClinicalTrials.gov NCT06081647, registered on October 15, 2023.

Indexed as

Airway ManagementEndoscopy, GastrointestinalHypoxiaAdultEquivalence Trials as TopicFemaleHumansHypnotics and SedativesMaleMiddle AgedMulticenter Studies as TopicOropharynxProcedural SedationPropofolRandomized Controlled Trials as TopicTreatment OutcomeHypnotics and SedativesPropofolCOMBO endoscopy oropharyngeal airwayGastrointestinal endoscopesHypoxiaSedation

Identifiers

PMID41390738
PMCPMC12817690

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.