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

May 7, 2019 updated by: Yonsei University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ACTUAL)

April 18, 2019

Study Completion (ACTUAL)

April 18, 2019

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (ACTUAL)

March 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2019

Last Update Submitted That Met QC Criteria

May 7, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 1-2018-0082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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