The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure
1 other identifier
interventional
1,200
1 country
10
Brief Summary
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing gastrointestinal endoscopy under propofol sedation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedStudy Start
First participant enrolled
December 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2025
CompletedJune 25, 2025
June 1, 2025
2 years
September 19, 2023
June 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of hypoxia
(75% ≤ SpO2 \< 90% for \<60 s)
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Secondary Outcomes (2)
The incidence of sub-clinical respiratory depression
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of severe hypoxia
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Other Outcomes (1)
The incidence of other adverse events
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Study Arms (2)
the COMBO Endoscopy Oropharyngeal Airway Group
EXPERIMENTALIn this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Regular Nasal Cannula Group
ACTIVE COMPARATORIn this group, patients use the regular nasal cannula for oxygenation.
Interventions
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Eligibility Criteria
You may qualify if:
- Age 18≤ Age ≤60.
- Patients undergoing gastroendoscopy and/or colonoscopy procedure.
- Patients have signed the informed consent form.
- The ASA classification ranges from I to II.
- The estimated duration of the procedure does not exceed 45 minutes.
You may not qualify if:
- Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement.
- Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs).
- Profound renal insufficiency necessitating preoperative dialysis.
- A confirmed severe liver dysfunction.
- Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy.
- Elevated intracranial pressure.
- Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions.
- Fever, defined as a core body temperature exceeding 37.5 degrees Celsius.
- Pregnancy or lactation.
- Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape.
- Urgent surgical intervention.
- Polytrauma.
- Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively.
- BMI\<18.5 or BMI\>30.
- Patients with a documented history of substance abuse, specifically drugs and/or alcohol, within the two years preceding the commencement of the screening period. Substance abuse in this context is defined as consuming more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (10)
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Shangdong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Renji Hospital
Shanghai, Shanghai Municipality, 200127, China
Tongji Hospital Of Tongji University
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affliated To Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghia, China
The First Affliated Hospital of Xi'an Jiangtong University
Xi’an, Shanxi, 710061, China
Tianjin Mediacal University General Hospital
Tianjin, Tianjin Municipality, 300052, China
The First Affliated Hospital, Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
Related Publications (1)
Zhang Y, Shi M, Qu Y, Cheng X, Zhang J, Guo S, Zheng Y, Su D. Efficacy and safety of the COMBO endoscopy oropharyngeal airway in gastrointestinal endoscopy: a study protocol for a multicenter randomized controlled trial. Trials. 2025 Dec 13. doi: 10.1186/s13063-025-09351-2. Online ahead of print.
PMID: 41390738DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Chair of the Department of Anesthesiology
Study Record Dates
First Submitted
September 19, 2023
First Posted
October 13, 2023
Study Start
December 27, 2023
Primary Completion
December 27, 2025
Study Completion
December 27, 2025
Last Updated
June 25, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
Deidentified participant data (including data dictionaries) and analysis codes generated in this study are available upon reasonable request. Additional documents, such as the study protocol and statistical analysis plan, can also be provided. Data will be accessible beginning 3 months after article publication for at least 5 years. Researchers seeking access must submit a request to the corresponding author for approval, which will be granted based on scientific merit and compliance with a data sharing agreement.