Suleyman Demirel University
Isparta, Merkez, 32200, Turkey (Türkiye)
NCT Number: NCT06107998
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Isparta, Merkez, 32200, Turkey (Türkiye)
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
endotracheal tube cuff will be inflated via stethoscope guidance
endotracheal tube cuff will be inflated via audible leak/balloon palpation method
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).
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).
Time frame: After induction of anesthesia and intubation
The authors will also investigate whether cuff pressure adjustments vary by endotracheal tube diameter (Millimeter/mm)
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.
Suleyman Demirel University
Other
Comparison of the Audible Leak-balloon Palpation Method and the Stethoscope-guided Method for Endotracheal Tube Cuff Inflation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03841890
Anesthesia, General, Intubation, Intratracheal
Taoyuan, Taiwan
View Trial DetailsNCT06220136
Anesthesia, General, Neuromuscular Blockade
Ankara, Altındağ, Turkey (Türkiye)
View Trial DetailsNCT07516470
Anesthesia, General, Fluid Responsiveness Predictability
Seoul, South Korea
View Trial DetailsNCT07707440
Anesthesia, General, Laparoscopic Cholecystectomy
Istanbul, Turkey (Türkiye)
View Trial Details