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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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ClinicalTrials.gov Identifier: NCT03872674
Recruitment Status : Completed
First Posted : March 13, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone Position Biological: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Arm 1: standard nasal cannula group Arm 2: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) group
Masking: None (Open Label)
Masking Description: Patients will be randomly allocated to 2 groups using computer-generated randomization method. Neither participants nor physicians will be blinded to the groups because of organizational reasons
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial Comparing High-flow Nasal Oxygen With Standard Management for Conscious Sedation During Endoscopic Retrograde Cholangiopancreatography in Prone Position
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : April 18, 2019
Actual Study Completion Date : April 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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.




Primary Outcome Measures :
  1. lowest SpO2 measured with pulse oximetry during the procedure [ Time Frame: 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 :
  1. incidence of desaturation below 90% during the procedure [ Time Frame: 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872674


Locations
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Korea, Republic of
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03872674     History of Changes
Other Study ID Numbers: 1-2018-0082
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action