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High Flow Nasal Oxygenation and Gastric Insufflation in Anesthetized Patients

Primary Purpose

Gastric Distention

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
THRIVE
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Distention

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ajou University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HFNO arm

Arm Description

Patients will receive HFNO therapy during laryngomicrosurgery.

Outcomes

Primary Outcome Measures

change of gastric volume
Ultrasound exam will measure the antral cross-sectional area of gastric antrum

Secondary Outcome Measures

Full Information

First Posted
November 10, 2020
Last Updated
January 3, 2022
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04629911
Brief Title
High Flow Nasal Oxygenation and Gastric Insufflation in Anesthetized Patients
Official Title
The Effect of High Flow Nasal Oxygenation on Gastric Insufflation in Paralyzed Anesthetized Patients Undergoing Laryngologic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 23, 2020 (Actual)
Primary Completion Date
August 24, 2021 (Actual)
Study Completion Date
August 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Distention

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFNO arm
Arm Type
Experimental
Arm Description
Patients will receive HFNO therapy during laryngomicrosurgery.
Intervention Type
Device
Intervention Name(s)
THRIVE
Other Intervention Name(s)
Optiflow
Intervention Description
Patients will receive HFNO therapy during laryngomicrosurgery. Patients will undergo a gastric ultrasound examination after HFNO therapy.
Primary Outcome Measure Information:
Title
change of gastric volume
Description
Ultrasound exam will measure the antral cross-sectional area of gastric antrum
Time Frame
before HFNO application (baseline), immediately after HFNO application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeongki-do
ZIP/Postal Code
443-721
Country
Korea, Republic of

12. IPD Sharing Statement

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High Flow Nasal Oxygenation and Gastric Insufflation in Anesthetized Patients

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