Effect of High Flow Nasal Cannula on Oxygenation During Urodynamic Study in Pediatric Population

April 20, 2020 updated by: Jin-Tae Kim, Seoul National University Hospital
To evaluate the effect of high flow nasal cannula for prevention of hypoxia during deep sedation in pediatric population

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

82

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, 110-744
        • Recruiting
        • Seoul National University Hospital

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 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged <7 years
  • ASA class I, II

Exclusion Criteria:

  • Respiratory disease
  • Pneumothorax
  • Increased ICP
  • Nasal bleeding
  • Previous airway surgery
  • Trauma
  • Pulmonary hypertension

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Children in the control group receive oxygen via conventional nasal cannula during deep sedation. Oxygen flow is determined to set the fraction of inspired oxygen of 50%.
Experimental: High flow (HF) group
Children in the HF group receive oxygen via high flow nasal cannula during deep sedation. Fraction of inspired oxygen is set to 50%.
Device: High flow nasal cannula
Oxygen is supplied via high flow nasal cannula. Heated air (2L/kg/min) is administered using Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of desaturation
Time Frame: During deep sedation (during approximately 1 hour after propofol infusion)
Incidence of peripheral pulse oximeter value lower than 95%
During deep sedation (during approximately 1 hour after propofol infusion)

Secondary Outcome Measures

Outcome Measure
Time Frame
Minimum pulse oximeter value
Time Frame: During deep sedation (during approximately 1 hour after propofol infusion)
During deep sedation (during approximately 1 hour after propofol infusion)
Incidence of peripheral pulse oximeter value lower than 90%
Time Frame: During deep sedation (during approximately 1 hour after propofol infusion)
During deep sedation (during approximately 1 hour after propofol infusion)
Incidence of changes in oxygen flow (control group) or FiO2 (HF group)
Time Frame: During deep sedation (during approximately 1 hour after propofol infusion)
During deep sedation (during approximately 1 hour after propofol infusion)
percutaneous CO2 value
Time Frame: During deep sedation (during approximately 1 hour after propofol infusion)
During deep sedation (during approximately 1 hour after propofol infusion)
Oxygen reserve index value
Time Frame: During deep sedation (during approximately 1 hour after propofol infusion)
During deep sedation (during approximately 1 hour after propofol infusion)
Incidence of manual ventilation
Time Frame: During deep sedation (during approximately 1 hour after propofol infusion)
During deep sedation (during approximately 1 hour after propofol infusion)

Collaborators and Investigators

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

Sponsor

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)

March 23, 2020

Primary Completion (Anticipated)

November 20, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

November 3, 2019

First Submitted That Met QC Criteria

November 3, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • H1910-038-1068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Desaturation

Clinical Trials on High flow nasal cannula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe