The Efficacy of Transnasal Humidified Rapid-insufflation Ventilatory Exchange During Laryngeal Microsurgery

November 19, 2020 updated by: Youn Joung Cho, MD, Seoul National University Hospital

The Efficacy of Transnasal Humidified Rapid-insufflation Ventilatory Exchange in Patients Undergoing Laryngeal Microsurgery: a Randomized Controlled Trial

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) was revealed to prolong apneic time with a slow increase in carbon dioxide; thus, has been used for preoxygenation in patients with difficult airways or requiring rapid sequence induction in general anesthesia.

However, in patients undergoing hypopharyngeal and laryngo-tracheal surgery, THRIVE during operation can be advantageous by allowing tubeless surgical field with sufficient oxygenation.

Therefore, the investigators conducted this study to evaluate the efficacy of THRIVE on prolonged apneic time with enhanced surgical conditions in patients with laryngeal microsurgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing laryngeal microsurgery will be randomized into either intubation group or THRIVE group.

On arriving operating room, the patients will be preoxygenated by facemask or high flow nasal cannula with 100% oxygen for 3 minutes according to the allocated group. After inducing general anesthesia, patients in intubation group will be oxygenated by endotracheal tube, while patients in THRIVE group will be oxygenated by high flow nasal cannula with flow rate of 70L/min. During the surgery, the endotracheal tube can be removed and reintubated in intubation group patients to provide surgical field by a surgeon, respectively.

The monitored pulse oximetry, oxygen reserve index, and transcutaneous partial pressure of carbon dioxide will be recorded during surgery.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing laryngeal microsurgery
  • ASA class I-III

Exclusion Criteria:

  • patients scheduled for laryngeal microsurgery using CO2 laser
  • patients with increased intracranial pressure
  • patients with skull base defect
  • patients with chronic obstructive pulmonary disease
  • patients with pulmonary hypertension
  • patients requiring rapid sequence induction

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: intubation group
The enrolled patients will be oxygenated by endotracheal tube during operation.
Procedure: endotracheal intubation
After preoxygenation with FiO2 1.0 and flow rate of 8 L/min for 3 minutes, the enrolled patients will be intubated with endotracheal tube and maintained oxygenation during surgery.
EXPERIMENTAL: THRIVE group
The enrolled patients will be oxygenated by intubationless high flow nasal cannula during operation.
Procedure: high flow nasal cannula
After preoxygenation with 100% oxygen through high flow nasal cannula for 3 minutes, the enrolled patients will be maintained intubationless oxygenation with flow rate of 70 L/min during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lowest oxygen saturation
Time Frame: from the time of starting laryngeal microsurgery till the end of the surgery
lowest oxygen saturation monitored by pulse oximetry during laryngeal microsurgery
from the time of starting laryngeal microsurgery till the end of the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lowest oxygen reserve index
Time Frame: from the time of starting laryngeal microsurgery till the end of the surgery
lowest oxygen reserve index monitored during laryngeal microsurgery
from the time of starting laryngeal microsurgery till the end of the surgery
highest transcutaneous partial pressure of carbon dioxide
Time Frame: from the time of starting laryngeal microsurgery till the end of the surgery
highest transcutaneous partial pressure of carbon dioxide monitored during laryngeal microsurgery
from the time of starting laryngeal microsurgery till the end of the surgery

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

August 17, 2018

Primary Completion (ACTUAL)

February 24, 2020

Study Completion (ACTUAL)

February 24, 2020

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (ACTUAL)

August 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • THRIVE during LMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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