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NCT03241979 Clinical Trial

THRIVE in Pediatric Laryngeal Microsurgery

Laryngoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03241979
Other study ID # H1706-204-866
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 7, 2017
Est. completion date June 3, 2019

Study information
Verified date April 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 3, 2019
Est. primary completion date June 3, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Years
Eligibility Inclusion Criteria: - pediatric patients undergoing laryngeal microsurgery with spontaneous ventilation Exclusion Criteria: - Severe gastrointestinal reflux disease Neuromuscular disease Central hypoventilation

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of SNUH Seoul Jongro Gu

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of low saturation events oxygen saturation decrease lower than 90% Intraoperative
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