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CompletedNCT03872674Updated May 9, 2019

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

An interventional study of high-flow humidified oxygen-delivery system (OptiFlow THRIVE) in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone Position, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-05-09.

Sponsored by Yonsei University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
19 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone Position
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In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • No intervention
    standard oxygenation(nasal cannula)

    stand oxygenation arm will receive oxygen at 5 L/min via nasal cannula

  • Experimental
    high-flow humidified oxygen-delivery system(OptiFlow THRIVE)

    Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE

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

Interventions

  • Biologicalhigh-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.

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What researchers measure

Primary outcomes

  1. lowest SpO2 measured with pulse oximetry during the procedure

    The investigators will record the lowest SpO2 during the procedure.

    Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)

Secondary outcomes

  1. incidence of desaturation below 90% during the procedure

    The investigators will compare the incidence of desaturation during the procedure between the two groups.

    Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)

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Study locations

1 site
  • Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
    Seoul, 03722, Korea, Republic of
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References and documents

Publications

  • Kim SH, Bang S, Lee KY, Park SW, Park JY, Lee HS, Oh H, Oh YJ. Comparison of high flow nasal oxygen and conventional nasal cannula during gastrointestinal endoscopic sedation in the prone position: a randomized trial. Can J Anaesth. 2021 Apr;68(4):460-466. doi: 10.1007/s12630-020-01883-2. Epub 2021 Jan 6. PubMed 33403549 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03872674
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Mar 13, 2019
Start date
Apr 1, 2019
Primary completion
Apr 18, 2019
Completion
Apr 18, 2019
Last update
May 9, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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