Comparison of Different Methods for Determining Endotracheal Cuff Pressure

January 3, 2024 updated by: Mustafa Soner Ozcan, Suleyman Demirel University

Comparison of the Audible Leak-balloon Palpation Method and the Stethoscope-guided Method for Endotracheal Tube Cuff Inflation

The goal of this clinical trial is to test whether the stethoscope can be used as a method of assessing endotracheal cuff pressure as effectively as a manometer and also to compare it with the balloon palpation/audible leak method frequently used in clinical practice in adult patients undergoing general anesthesia.

The main questions it aims to answer are:

  • Is the stethoscope as effective as a manometer in assessing endotracheal cuff pressure?
  • Is there a difference between stethoscope and audible leak/balloon palpation methods in assessing endotracheal cuff pressure? Participants will be randomly divided into 2 groups.
  • Group P: After intubation, endotracheal cuff pressure will be assessed by audible leak/balloon palpation.
  • Group S: After intubation, endotracheal cuff pressure will be assessed with a stethoscope.
  • Control will be carried out with a manometer and the pressure values obtained in the groups will be corrected.

Researchers will compare ''stethoscope'' and ''audible leak/balloon palpation'' groups to see if which method is effective like a manometer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although the use of a manometer is recommended in daily practice to evaluate endotracheal tube cuff pressure for intubated patients, the cuff is still inflated using balloon palpation or audible leakage methods in many centers. Manometers may not be available in most centers. An acceptable cuff pressure ranges from 20 to 30 cm H2O. While the risk of aspiration increases below 20 cm H2O, at values above 30 cm H2O the circulation of the tracheal mucosa begins to deteriorate and related complications like ulceration, stenosis, and even fistula may develop.

The authors hypothesize that the stethoscope is as effective as a manometer in assessing endotracheal tube cuff pressure where a manometer is not available.

After informed consent is obtained from patients who meet the inclusion criteria for the study, the patients will be intubated following anesthesia induction and the method by which the patients' endotracheal tube cuffs will be inflated will be determined in a randomized manner using the sealed envelope method. Then, the cuff pressures will be checked with a manometer by an expert who does not know the method by which the cuff is inflated, if necessary, it will be corrected and the data will be recorded with the code assigned to the method. Statistical evaluations will be made on the data obtained by an analyst who does not know the names of the methods and which method was applied to which patient.

The difference between our study and previous studies:

  • Previous studies had small numbers of patients.
  • The authors designed a randomized controlled study with triple masking.

Study Type

Interventional

Enrollment (Actual)

176

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

  • Turkey
    • Merkez
      • Isparta, Merkez, Turkey, 32200
        • Suleyman Demirel University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between the ages of 18-65
  • Planning the operation under general anesthesia
  • Performing endotracheal intubation during general anesthesia
  • Elective surgeries
  • Volunteering to participate in the study

Exclusion Criteria:

  • Having a history of difficult intubation before
  • Difficulty during intubation (repeated intubation attempts, etc.)
  • rapid sequence intubation requirement
  • Planning to undergo head and neck surgery
  • Those with tracheal stenosis
  • Previous intervention to the neck area (radiotherapy, tracheotomy, etc.)
  • Pregnancy
  • Obesity
  • Those with respiratory diseases (COPD, asthma, etc.)
  • Emergency surgery
  • American Society of Anaesthesiologists physical status>3
  • Refusing to participate in the study

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: Stethoscope
Patients whose endotracheal tube cuff is inflated via a stethoscope
Other: stethoscope
endotracheal tube cuff will be inflated via stethoscope guidance
Active Comparator: Audible leak/Balloon palpation
Patients whose endotracheal tube cuff is inflated via audible leak/balloon palpation method.
Other: Audible leak/Balloon palpation
endotracheal tube cuff will be inflated via audible leak/balloon palpation method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cuff pressure of air introduced
Time Frame: After the patients are intubated and tube cuff inflated
After the cuffs inflated using the specified methods are checked with a manometer, it will be noted whether there is any difference between the required pressures (centimeter of water/cm H2O).
After the patients are intubated and tube cuff inflated
cuff volume of air introduced
Time Frame: After the patients are intubated and tube cuff inflated
After the cuffs inflated using the specified methods are checked with a manometer, it will be noted whether there is any difference between the required additional volumes (milliliters/mL).
After the patients are intubated and tube cuff inflated

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endotracheal tube diameters
Time Frame: After induction of anesthesia and intubation
The authors will also investigate whether cuff pressure adjustments vary by endotracheal tube diameter (Millimeter/mm)
After induction of anesthesia and intubation
endotracheal tube brands
Time Frame: After induction of anesthesia and intubation
The authors will also investigate whether cuff pressure adjustments vary by endotracheal tube brands. The brands will be noted as A, B, C, D..etc.
After induction of anesthesia and intubation

Collaborators and Investigators

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

Sponsor

Suleyman Demirel University

Investigators

  • Principal Investigator: Mustafa Soner Özcan, M.D., Suleyman Demirel University,Faculty of Medicine, Department of Anesthesiology and Reanimation

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)

November 2, 2023

Primary Completion (Actual)

December 29, 2023

Study Completion (Actual)

January 2, 2024

Study Registration Dates

First Submitted

October 21, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SNR-10/143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After the study is finished, data from the study will be shared when reasonable reasons are presented.

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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