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

Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone Position Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03872674
• Other study ID #: 1-2018-0082
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 18, 2019

Study information

• Verified date: May 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 18, 2019
• Est. primary completion date: April 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone Position

Intervention

Biological:
• high-flow humidified oxygen-delivery system (OptiFlow THRIVE)
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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)