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Hypoxia represents the most frequent adverse event during propofol-sedated gastrointestinal endoscopy. The STOP-BANG questionnaire serves as a widely adopted, straightforward tool for screening obstructive sleep apnea (OSA) risk, with a score ≥5 identifying high-risk OSA patients who are particularly susceptible to hypoxia under sedation. Although preliminary research from our team suggests that High-Flow Nasal Cannula (HFNC) may lower the incidence of hypoxemia, evidence remains limited and inconsistent in studies specifically targeting high-risk OSA populations. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxia during sedated gastrointestinal endoscopy in patients identified as high-risk for OSA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-flow nasal cannula Group | Experimental | In this group, patients use the High-flow nasal cannula |
|
| 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 |
|---|---|---|---|---|
| High-flow nasal cannula Group | Device | Using High-flow nasal cannula 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, Chief Physician | Contact | +8618616514088 | diansansu@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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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 Hospital Of Jiaxing | Recruiting | Jiaxing | Zhejiang | 314000 | China |
|
| Quzhou People's Hospital | Recruiting | Quzhou | Zhejiang | 324000 | China |
|
| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D004194 | Disease |
| D020181 | Sleep Apnea, Obstructive |
| 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 |
| D010335 | Pathologic Processes |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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