NCT03241979

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

August 7, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2019

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

1.8 years

First QC Date

July 28, 2017

Last Update Submit

April 19, 2021

Conditions

Laryngoscopy

Outcome Measures

Primary Outcomes (1)

  • number of low saturation events

    oxygen saturation decrease lower than 90%

    Intraoperative

Study Arms (1)

laryngeal microsurgery

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients

You may qualify if:

  • pediatric patients undergoing laryngeal microsurgery with spontaneous ventilation

You may not qualify if:

  • Severe gastrointestinal reflux disease Neuromuscular disease Central hypoventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUH

Seoul, Jongro Gu, 15710, South Korea

Location

Related Publications (1)

  • Kim EH, Ji SH, Lee JH, Kim JT, Jang YE, Kwon SK, Kim HS. Use of high-flow nasal oxygen in spontaneously breathing pediatric patients undergoing tubeless airway surgery: A prospective observational study. Medicine (Baltimore). 2022 Jul 8;101(27):e29520. doi: 10.1097/MD.0000000000029520.

    PMID: 35801795DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 8, 2017

Study Start

August 7, 2017

Primary Completion

June 3, 2019

Study Completion

June 3, 2019

Last Updated

April 21, 2021

Record last verified: 2021-04

Locations

KR(1)