THRIVE in Pediatric Laryngeal Microsurgery

April 19, 2021 updated by: Hee-Soo Kim, Seoul National University Hospital

The Effects of Transnasal Humidified Rapid Insufflation Ventilator Exchange (THRIVE) on the Oxygenation in Pediatric Patients Under Tubeless Airway Surgery - a Physiologic Study

Transnasal High-flow rapid-insufflation ventilatory exchange (THRIVE) has been shown to benefit oxygenation, ventilation and upper airway patency in a range of clinical scenarios, however its use in spontaneously breathing pediatric patients undergoing tubeless airway surgery has not been described. This is a physiologic study that evaluates the feasibility of THRIVE during pediatric airway surgery under self-respiration.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

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

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

Sampling Method

Non-Probability Sample

Study Population

pediatric patients

Description

Inclusion Criteria:

  • pediatric patients undergoing laryngeal microsurgery with spontaneous ventilation

Exclusion Criteria:

  • Severe gastrointestinal reflux disease Neuromuscular disease Central hypoventilation

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
laryngeal microsurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of low saturation events
Time Frame: Intraoperative
oxygen saturation decrease lower than 90%
Intraoperative

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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)

August 7, 2017

Primary Completion (Actual)

June 3, 2019

Study Completion (Actual)

June 3, 2019

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

August 5, 2017

First Posted (Actual)

August 8, 2017

Study Record Updates

Last Update Posted (Actual)

April 21, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • H1706-204-866

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

product manufactured in and exported from the U.S.

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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