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

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Yonsei University

Status

Completed

Conditions

Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone Position

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03872674
1-2018-0082

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

    1. patients who will undergo endoscopic retrograde cholangiopancreatography under conscious sedation

Exclusion criteria

    1. dementia or cognitive dysfunction
    1. altered mental status
    1. intubated patients or tracheostomy
    1. pregnancy
    1. recent history of nasal bleeding
    1. illiteracy or foreigner

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

standard oxygenation(nasal cannula)
No Intervention group
Description:
stand oxygenation arm will receive oxygen at 5 L/min via nasal cannula
high-flow humidified oxygen-delivery system(OptiFlow THRIVE)
Experimental group
Description:
Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE
Treatment:
Biological: high-flow humidified oxygen-delivery system (OptiFlow THRIVE)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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