A Trial Comparing High-flow Nasal Oxygen With Standard Management for Conscious Sedation During Endoscopic Retrograde Cholangiopancreatography in Prone Position

Study Overview
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Brief Summary
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Traditional conscious sedation for endoscopic retrograde cholangiopancreatography in prone position places patients at risk of desaturation, and high-flow nasal oxygen may reduce the risk. The aim of this study is to evaluate the role of high-flow nasal oxygen during endoscopic retrograde cholangiopancreatography. The investigators will compare the lowest SpO2 of standard nasal oxygen cannula group and that of high-flow humidified oxygen-delivery system group during the procedure.

Official Title
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A Randomized Controlled Trial Comparing High-flow Nasal Oxygen With Standard Management for Conscious Sedation During Endoscopic Retrograde Cholangiopancreatography in Prone Position

Conditions
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Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone Position

Intervention / Treatment
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* Biological: high-flow humidified oxygen-delivery system (OptiFlow THRIVE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. patients who will undergo endoscopic retrograde cholangiopancreatography under conscious sedation Exclusion Criteria: 1. dementia or cognitive dysfunction 2. altered mental status 3. intubated patients or tracheostomy 4. pregnancy 5. recent history of nasal bleeding 6. illiteracy or foreigner

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1: standard nasal cannula group Arm 2: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard oxygenation(nasal cannula)<br>stand oxygenation arm will receive oxygen at 5 L/min via nasal cannula | |
| Experimental: high-flow humidified oxygen-delivery system(OptiFlow THRIVE)<br>Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE | Biological: high-flow humidified oxygen-delivery system (OptiFlow THRIVE)<br>* stand oxygenation arm will receive oxygen at 5 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lowest SpO2 measured with pulse oximetry during the procedure | The investigators will record the lowest SpO2 during the procedure. | during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of desaturation below 90% during the procedure | The investigators will compare the incidence of desaturation during the procedure between the two groups. | during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography) |