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| Name | Class |
|---|---|
| Henan Provincial People's Hospital | OTHER |
| First Affiliated Hospital of Kunming Medical University | OTHER |
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Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol. The nasal mask oxygen kit has good sealing to ensure an adequate oxygen supply and is convenient and economical.The aim of this randomized study was to determine whether the nasal mask oxygen kit reduces the incidence of hypoxia in gastrointestinal endoscopes procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nasal mask oxygen group | Experimental | In this group, patients use the nasal mask oxygen kit 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 |
|---|---|---|---|---|
| nasal mask oxygen kit | Device | Using the nasal mask oxygen kit 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450003 | China | ||
| Renji Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40623715 | Derived | Cheng X, Zhang X, Zhang J, Hu Z, Zhang J, Lian Q, Ding X, He Y, Shi M, Zhang Y, Tian M, Zheng H, Li Z, Wang Y, Yu W, Shao J, Su D. Efficacy of a nasal mask oxygen kit versus regular nasal cannula in sedated gastrointestinal endoscopy: a multicentre, randomised clinical trial. BMJ Open Gastroenterol. 2025 Jul 7;12(1):e001834. doi: 10.1136/bmjgast-2025-001834. |
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Beginning 3months and ending 5 years following article publication.
The data will be available to other researchers upon request, with information shared after approval by the corresponding author (D-SS).
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D013274 | Stomach Neoplasms |
| C562464 | Polyposis, Gastric |
| D003111 | Colonic Polyps |
| D003110 | Colonic Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005770 | Gastrointestinal Neoplasms |
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| regular nasal cannula |
| Device |
Using 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 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] |
| Shanghai |
| Shanghai Municipality |
| 200127 |
| China |
| First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650032 | China |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |