Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients

February 22, 2024 updated by: Jin-Tae Kim, Seoul National University Hospital
The investigators evaluate the efficacy and safety of routine administration of oxygen during moderate or deep sedation in pediatric patients. In addition, in terms of efficacy and safety, oxygen administration via nasal prong and high flow nasal cannula will be compared.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

258

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

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:

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

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children under the age of 18 who undergo moderate-deep sedation

Exclusion Criteria:

  • Respiratory failure patients
  • Increased intracranial pressure
  • Recent massive nasal bleeding
  • History of airway surgery
  • Complete nasal obstruction
  • Pulmonary hypertension
  • Skull base fracture

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Nasal prong is applied, but sedation is performed without oxygen administration.
Experimental: Low flow group
Oxygen administration by nasal cannula
Device: nasal prong
Oxygen is administered via nasal prong
Experimental: High flow group
Oxygen is administered at a rate of 2L/kg/min using an Optiflow device
Device: high flow nasal cannula
The heated air is administered at a rate of 2L/kg/min using an Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand). Inhalation oxygen concentration starts with 50%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desaturation (≤95%)
Time Frame: through study completion, average 30 minutes
Occurrence of desaturation (pulse oximeter ≤95%)
through study completion, average 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desaturation (≤90%)
Time Frame: through study completion, average 30 minutes
Occurrence of desaturation (pulse oximeter ≤90%)
through study completion, average 30 minutes
CO2 value
Time Frame: through study completion, average 30 minutes
percutaneous CO2 (maximum, minimum, mean values)
through study completion, average 30 minutes
Minimum saturation during sedation
Time Frame: through study completion, average 30 minutes
through study completion, average 30 minutes
Complications
Time Frame: through study completion, average 30 minutes
Any complications during sedation
through study completion, average 30 minutes

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jin-Tae Kim, MD, PhD, Seoul National University Hospital

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)

July 27, 2021

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

April 15, 2021

First Submitted That Met QC Criteria

April 15, 2021

First Posted (Actual)

April 21, 2021

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • H2103-095-1205

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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