THRIVE in Pediatric Laryngeal Microsurgery
Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03241979
Collaborator
(none)
30
1
21.8
1.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effects of Transnasal Humidified Rapid Insufflation Ventilator Exchange (THRIVE) on the Oxygenation in Pediatric Patients Under Tubeless Airway Surgery - a Physiologic Study
Actual Study Start Date
:
Aug 7, 2017
Actual Primary Completion Date
:
Jun 3, 2019
Actual Study Completion Date
:
Jun 3, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| laryngeal microsurgery
|
Outcome Measures
Primary Outcome Measures
- number of low saturation events [Intraoperative]
oxygen saturation decrease lower than 90%
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- pediatric patients undergoing laryngeal microsurgery with spontaneous ventilation
Exclusion Criteria:
- Severe gastrointestinal reflux disease Neuromuscular disease Central hypoventilation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SNUH | Seoul | Jongro Gu | Korea, Republic of | 15710 |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hee-Soo Kim,
professor,
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT03241979
Other Study ID Numbers:
- H1706-204-866
First Posted:
Aug 8, 2017
Last Update Posted:
Apr 21, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No