Comparison of Different Methods for Determining Endotracheal Cuff Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-02

Study Completion Date

2024-01-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia, General Intubation, Intratracheal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Only the person who intubates the patient and inflates the cuff using a method will know what the procedure is.

Study Groups

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Stethoscope

Patients whose endotracheal tube cuff is inflated via a stethoscope

Group Type EXPERIMENTAL

stethoscope

Intervention Type OTHER

endotracheal tube cuff will be inflated via stethoscope guidance

Audible leak/Balloon palpation

Patients whose endotracheal tube cuff is inflated via audible leak/balloon palpation method.

Group Type ACTIVE_COMPARATOR

Audible leak/Balloon palpation

Intervention Type OTHER

endotracheal tube cuff will be inflated via audible leak/balloon palpation method

Interventions

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stethoscope

endotracheal tube cuff will be inflated via stethoscope guidance

Intervention Type OTHER

Audible leak/Balloon palpation

endotracheal tube cuff will be inflated via audible leak/balloon palpation method

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No