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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the COMBO Endoscopy Oropharyngeal Airway Group | Experimental | In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation. |
|
| Regular Nasal Cannula Group | Active Comparator | In this group, patients use the regular nasal cannula for oxygenation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the COMBO Endoscopy Oropharyngeal Airway | Device | Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of sub-clinical respiratory depression | (90% ≤ SpO2 < 95%) | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| The incidence of severe hypoxia |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of other adverse events | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diansan Su, Dr. | Contact | +862168383702 | diansansu@yahoo.com | |
| Yuhan Zhang, B.S | Contact | +862168383702 | 1092619255@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41390738 | Derived | 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;27(1):51. doi: 10.1186/s13063-025-09351-2. |
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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.
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| Regular Nasal Cannula | Device | Using regular nasal cannula for oxygenation. |
|
(SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s)
| Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| The First Affiliated Hospital Of Nanchang University | Recruiting | Nanchang | Jiangxi | China |
|
| Shangdong Provincial Qianfoshan Hospital | Recruiting | Jinan | Shandong | 250014 | China |
|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
|
| Tongji Hospital Of Tongji University | Recruiting | Shanghai | Shanghai Municipality | China |
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| Xinhua Hospital Affliated To Shanghai Jiaotong University School Of Medicine | Recruiting | Shanghai | Shanghia | China |
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| The First Affliated Hospital of Xi'an Jiangtong University | Recruiting | Xi’an | Shanxi | 710061 | China |
|
| Tianjin Mediacal University General Hospital | Recruiting | Tianjin | Tianjin Municipality | 300052 | China |
|
| The First Affliated Hospital, Zhejiang University School Of Medicine | Recruiting | Hangzhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D000860 | Hypoxia |
| C562464 | Polyposis, Gastric |
| D003110 | Colonic Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
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