A Comparison of High-flow Nasal Oxygen and Conventional Nasal Cannula in Monitored Anesthesia Care for Endoscopic Submucosal Dissection

November 13, 2024 updated by: Yonsei University
Sedation for endoscopic submucosal dissection 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 submucosal dissection. We will compare the incidence of hypoxemia (defined as SpO2 lower than 90%) of conventional nasal oxygen cannula group and that of high-flow humidified oxygen-delivery system group during the procedure.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

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 Contact

  • Name: Namo Kim
  • Phone Number: 82-2-2224-3200
  • Email: namo@yuhs.ac

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients who will undergo endoscopic sumucosal dissection under remimazolam-based sedation

Exclusion Criteria:

  • dementia or cognitive dysfunction
  • altered mental status
  • intubated patients or tracheostomy
  • pregnancy
  • recent history of nasal bleeding
  • contraindication for positive pressure ventilation
  • patients under oxygen therapy
  • 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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: conventional oxygenation (nasal cannula) arm
conventional oxygenation arm will receive oxygen at 2L/min via nasal cannula
Device: conventional oxygenation (nasal cannula)
conventional oxygenation arm will receive oxygen at 2 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure.
Experimental: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) arm
Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE
Device: high-flow humidified oxygen-delivery system (OptiFlow THRIVE)
conventional oxygenation arm will receive oxygen at 2 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
The incidence of hypoxemia (SpO2 lower than 90%) measured with pulse oximetry during the procedure
Time Frame: during the procedure (from the start to the end of the endoscopic submucosal dissection), 1hour
We will record the incidence of hypoxemia during the procedure.
during the procedure (from the start to the end of the endoscopic submucosal dissection), 1hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number and duration of hypoxemia
Time Frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
We will compare the number and duration of hypoxemia, the lowest SpO2 during procedure, need for airway intervention, the end tidal CO2 at the end of the procedure between the two groups.
during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
the lowest SpO2 during procedure
Time Frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
We will compare the number and duration of hypoxemia, the lowest SpO2 during procedure, need for airway intervention, the end tidal CO2 at the end of the procedure between the two groups.
during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
need for airway intervention
Time Frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
We will compare the number and duration of hypoxemia, the lowest SpO2 during procedure, need for airway intervention, the end tidal CO2 at the end of the procedure between the two groups.
during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
the end tidal CO2 at the end of the procedure
Time Frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
We will compare the number and duration of hypoxemia, the lowest SpO2 during procedure, need for airway intervention, the end tidal CO2 at the end of the procedure between the two groups.
during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour

Collaborators and Investigators

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

Sponsor

Yonsei University

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 (Estimated)

November 1, 2024

Primary Completion (Estimated)

October 18, 2025

Study Completion (Estimated)

October 18, 2025

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Estimated)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 4-2024-1108

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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