Observation of the Pressure Changes of the Endotracheal Tube Cuff in the Head and Neck Surgery Under General Anesthesia

May 28, 2021 updated by: Yonsei University
Endotracheal tube is a commonly used for general anesthesia in head and neck surgery. It is necessary to place the endotracheal tube in the trachea of the patient and then inflate the cuff with air. This is because the air-inflated cuff contacts the inner wall of the patient's trachea to deliver oxygen through the tube. If the cuff does not inflate, oxygen will leak through the space between the cuff and the patient's trachea. In addition, the risk of pneumonia increases. Therefore, after placing the endotracheal tube in the patient's trachea, the cuff is immediately inflated with air. However, when the cuff is inflated using an excess of air, the cuff may pressurize the mucous membrane of the tracheal wall and cause ischemia. Pressure in the over-inflated cuff was also found to be associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Therefore, appropriate amount of air should be used to inflate the cuff into the air and adjust the pressure within the cuff to be within the range of 20-30 cmH2O. The authors thought that the pressure in the cuff could be changed during the operation due to various factors and that the pressure in the cuff should be monitored continuously. In this study, the investigators will monitor the cuff pressure during anesthesia and analyze the factors affecting the cuff pressure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

201

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

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

Sampling Method

Probability Sample

Study Population

Adults who require endotracheal intubation for head and neck surgery under general anesthesia

Description

Inclusion Criteria:

  • 1. Adults who require endotracheal intubation for head and neck surgery under general anesthesia

Exclusion Criteria:

  • 1. Patients under 20 years old
  • 2. Patients who should undergo tracheostomy
  • 3. Patients who need to use an endotracheal tube without a cuff
  • 4. Pregnant women
  • 5. Patients who can not read the consent form or are not fluent in Korean
  • 6. Patients who refused the clinical trial

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
endotracheal intubation under general anesthesia
Adults who require endotracheal intubation for head and neck surgery under general anesthesia
Other: monitoring of the endotracheal tube cuff
We will enroll adult patients who will undergo endotracheal intubation for general anesthesia of head and neck surgery. The cuff pressure of the endotracheal tube will be monitored continuously during anesthesia. The cuff pressure value will be recorded and analyzed after completing the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of cuff pressure during anesthesia
Time Frame: participants will followed until post-operative 1 day.
The investigators will monitor the pressure of the endotracheal tube cuff during anesthesia. The changes of the cuff pressure from the baseline value will be monitored continuously.
participants will followed until post-operative 1 day.

Collaborators and Investigators

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

Sponsor

Yonsei University

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)

April 28, 2020

Primary Completion (Actual)

November 4, 2020

Study Completion (Actual)

November 4, 2020

Study Registration Dates

First Submitted

May 3, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Actual)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4-2019-0100

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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