Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Hypoxia is the most common adverse event during propofol sedation for gastrointestinal endoscopy, particularly in obese patients.
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 this study is to evaluate the efficacy of the COMBO Endoscopy Oropharyngeal Airway in combination with High-Flow Nasal Cannula Oxygenation for reducing the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation | Experimental | In this group, patients use the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation | Device | Using the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Obese Patients |
| 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 subclinical 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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41714955 | Derived | Xu M, Xiang S, Feng Y, Guo S, Zhang W, Hu Z, Zhang X, Zheng Y, Su D. Combination of COMBO endoscopy oropharyngeal airway and high-flow nasal cannula oxygenation in sedated gastrointestinal endoscopy for morbidly obese patients: a Simon two-stage trial. BMC Anesthesiol. 2026 Feb 19;26(1):195. doi: 10.1186/s12871-026-03708-z. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Combined use of the COMBO Endoscopy Oropharyngeal Airway with high-flow nasal Cannula Oxygenation in morbidly obese patients undergoing endoscopy
Not provided
Not provided
Not provided
Not provided
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 |
| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided