Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03872674    
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No