Transnasal Humidified Rapid Insufflation System for Intubation

February 16, 2020 updated by: Youn Yi Jo, Gachon University Gil Medical Center

Effect of Transnasal Humidified Rapid Insufflation Ventilator Exchange During Anesthesia Induction With Double Lumen Endotracheal Tube

Transnasal humidified rapid insufflation ventilator exchange (THRIVE) or not during the anesthesia induction

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Control group-usual mask ventilation during apnea for anesthetic intubation and check tube positioning THRIVE group-applying THRIVE during apnea for anesthetic intubation and check tube positioning

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who scheduled for elective lung surery with one lung ventilation

Exclusion Criteria:

  • suspicious difficult intubation (BMI >35kg/m2, mouth opening < 3 finger, Mallampati G >3), Room air SpO2 < 90%, active pulmonary infection, emergency operation, pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
usual mask ventilation during anethesia induction
Device: Conventional face mask
applying oxygen using usual face mask
Active Comparator: THRIVE
Applying Transnasal humidified rapid insufflation ventilator exchange during anesthesia induction
Device: Transnasal humidified rapid insufflation ventilator exchange
applying 40L of oxygen for 1min and afte that increase oxygen flow up to 70L for 1 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desaturation
Time Frame: during the anesthesia induciton
number of patients who experienced SpO2 under 93%
during the anesthesia induciton

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 25, 2020

Primary Completion (Anticipated)

November 30, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

January 20, 2020

First Submitted That Met QC Criteria

January 20, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 16, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gil2019-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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