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Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) 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 this study is to assess the efficacy of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in patients undergoing ERCP under 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. |
|
| 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 | |
|---|---|---|---|---|
| DiSan Head of Anesthesiology, PhD | Contact | 86+18616514088 | 184872238@qq.com | |
| Lianjuan Sun, Master | Contact | +8618257152767 | sunlianjuan26@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| he First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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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,Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| ID | Term |
|---|---|
| D041781 | Jaundice, Obstructive |
| D010195 | Pancreatitis |
| D002769 | Cholelithiasis |
| D012131 | Respiratory Insufficiency |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D007565 | Jaundice |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D001660 | Biliary Tract Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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