High Flow Nasal Oxygenation and Gastric Insufflation in A... | NCT04629911

Studies
High Flow Nasal Oxygenation and Gastric Insufflation in Anesthetized Patients

NCT04629911

Sponsor

Ajou University School of Medicine

Status

Completed

Last Update Posted

Jan 5, 2022Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Gastric Distention

Interventions

THRIVE

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

Jan 2022

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

Nov 23, 2020Actual

Primary Completion Date

Aug 24, 2021Actual

Completion Date

Aug 24, 2021Actual

First Submitted Date

Nov 10, 2020

First Submission Date that Met QC Criteria

Nov 10, 2020

First Posted Date

Nov 16, 2020Actual

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

Jan 3, 2022

Last Update Posted Date

Jan 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 humidified rapid-insufflation ventilatory exchange(THRIVE), or also termed high flow nasal oxygenation (HFNO) is a method of supplying heated, humidified high concentrations of oxygen via nasal cavity.

The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.

Detailed Description

HFNO can be used during intraoperative period. HFNO reduces the risk of desaturation and prolongs the safe apnea time, compared with conventional oxygenation.

In laryngeal microsurgery, HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords.

HFNO have a risk for low level of positive pressure can make gastric distension, but gastric reflux or aspiration were not occurred during rapid sequence induction for emergency operation.

The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HFNO arm	Experimental	Patients will receive HFNO therapy during laryngomicrosurgery.	Device: THRIVE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
THRIVE	Device	Patients will receive HFNO therapy during laryngomicrosurgery. Patients will undergo a gastric ultrasound examination after HFNO therapy.	HFNO arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of gastric volume	Ultrasound exam will measure the antral cross-sectional area of gastric antrum	before HFNO application (baseline), immediately after HFNO application

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiology physical status classification I and II
Patients scheduled for laryngeal microsurgery under general anesthesia

Exclusion Criteria:

gastroesophageal reflux
gastric pathology
pregnancy
major cardiovascular, pulmonary, or cerebrovascular disease
severe obesity (body mass index>35 kg/m2)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajou University Hospital		Suwon	Gyeongki-do	443-721	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D061485	Tobacco Use Cessation Devices

Ancestor Terms

ID	Term
D013812	Therapeutics

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Browse Branches

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