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Hypoxaemia during sedated gastrointestinal endoscopy exceeds 40 % in morbidly obese (BMI ≥ 35 kg m-²) patients. High-flow nasal cannula alone often fails because of persistent airway collapse. 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.The purpose of this study is to investigate whether the combination of the COMBO Endoscopy Oropharyngeal Airway and High-Flow Nasal Cannula oxygenation reduces the incidence of hypoxemia in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| High-Flow Nasal Cannula Oxygenation | Active Comparator | In this group, patients use the High-Flow Nasal Cannula Oxygenation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 morbidly obese patients |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of hypoxemia | 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 hypoxaemia |
| 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, Chief Physician | Contact | +8618616514088 | diansansu@yahoo.com | |
| Mingxia Xu | Contact | +8613516713435 | xumingxia@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| High-Flow Nasal Cannula Oxygenation | Device | In this group, patients use high-flow nasal cannula 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 |
| Jinjiang Municipal Hospital | Recruiting | Jinjiang | Fujian | 362200 | China |
|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| The Fifth Affiliated Hospital of Wenzhou Medical University | Recruiting | Lishui | Zhejiang | 310000 | China |
|
| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | Zhejiang | 310000 | China |
|
| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| 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 |
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