Comparison of Different Methods for Determining Endotracheal Cuff Pressure

Study Overview
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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.

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.

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

Conditions
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Anesthesia, General, Intubation, Intratracheal

Intervention / Treatment
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* Other: stethoscope
* Other: Audible leak/Balloon palpation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stethoscope<br>Patients whose endotracheal tube cuff is inflated via a stethoscope | Other: stethoscope<br>* endotracheal tube cuff will be inflated via stethoscope guidance<br>|
| Active Comparator: Audible leak/Balloon palpation<br>Patients whose endotracheal tube cuff is inflated via audible leak/balloon palpation method. | Other: Audible leak/Balloon palpation<br>* endotracheal tube cuff will be inflated via audible leak/balloon palpation method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cuff pressure of air introduced | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cuff pressure, Endotracheal intubation, endotracheal tube, inflation, measurement