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

Not Applicable

Completed

• Conditions: Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone Position
• Interventions: Biological: high-flow humidified oxygen-delivery system (OptiFlow THRIVE)

• Registration Number: NCT03872674
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-13
• Study Start: 2019-04-01
• Primary Completion: 2019-04-18
• Study Completion: 2019-04-18
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-07
• Last Update Posted: 2019-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high-flow humidified oxygen-delivery system(OptiFlow THRIVE)	high-flow humidified oxygen-delivery system (OptiFlow THRIVE)	Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE

Primary Outcome Measures

Name	Time	Method
lowest SpO2 measured with pulse oximetry during the procedure	during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)	The investigators will record the lowest SpO2 during the procedure.

Secondary Outcome Measures

Name	Time	Method
incidence of desaturation below 90% during the procedure	during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)	The investigators will compare the incidence of desaturation during the procedure between the two groups.

Trial Locations

Locations (1)

Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of