THRIVE in Pediatric Laryngeal Microsurgery | NCT03241979

Studies
THRIVE in Pediatric Laryngeal Microsurgery

NCT03241979

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Apr 21, 2021Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Laryngoscopy

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 7, 2017Actual

Primary Completion Date

Jun 3, 2019Actual

Completion Date

Jun 3, 2019Actual

First Submitted Date

Jul 28, 2017

First Submission Date that Met QC Criteria

Aug 5, 2017

First Posted Date

Aug 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2021

Last Update Posted Date

Apr 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
laryngeal microsurgery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pediatric patients undergoing laryngeal microsurgery with spontaneous ventilation

Exclusion Criteria:

Severe gastrointestinal reflux disease Neuromuscular disease Central hypoventilation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Years

Standard Ages

Child

Study Population

pediatric patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SNUH		Seoul	Jongro Gu	15710	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35801795	Derived	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.