Clinical trial NCT06107998: Comparison of Different Methods for Determining Endotracheal Cuff Pressure
Official title: Comparison of the Audible Leak-balloon Palpation Method and the Stethoscope-guided Method for Endotracheal Tube Cuff Inflation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, General
Intubation, Intratracheal
Keywords: Cuff pressure
Endotracheal intubation
endotracheal tube
inflation
measurement
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: cuff pressure of air introduced
timeFrame: After the patients are intubated and tube cuff inflated
measure: cuff volume of air introduced
timeFrame: After the patients are intubated and tube cuff inflated
Secondary outcomes:
measure: endotracheal tube diameters
timeFrame: After induction of anesthesia and intubation
measure: endotracheal tube brands
timeFrame: After induction of anesthesia and intubation
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University
state: Merkez
Study officials:
affiliation: Suleyman Demirel University,Faculty of Medicine, Department of Anesthesiology and Reanimation
name: Mustafa Soner Özcan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar CM, Seet E, Van Zundert TCRV. Measuring endotracheal tube intracuff pressure: no room for complacency. J Clin Monit Comput. 2021 Feb;35(1):3-10. doi: 10.1007/s10877-020-00501-2. Epub 2020 Mar 20.
citation: Duarte NMDC, Caetano AMM, Arouca GO, Ferrreira AT, Figueiredo JL. [Subjective method for tracheal tube cuff inflation: performance of anesthesiology residents and staff anesthesiologists. Prospective observational study]. Braz J Anesthesiol. 2020 Jan-Feb;70(1):9-14. doi: 10.1016/j.bjan.2019.09.010. Epub 2020 Feb 19.
citation: Borhazowal R, Harde M, Bhadade R, Dave S, Aswar SG. Comparison between Two Endotracheal Tube Cuff Inflation Methods; Just-Seal Vs. Stethoscope-Guided. J Clin Diagn Res. 2017 Jun;11(6):UC01-UC03. doi: 10.7860/JCDR/2017/26301.10017. Epub 2017 Jun 1.
citation: Satya Prakash MVS, Aravind C, Mohan VK. Comparative evaluation of three methods of endotracheal tube cuff inflation for adequacy of seal. J Anaesthesiol Clin Pharmacol. 2022 Oct-Dec;38(4):588-593. doi: 10.4103/joacp.JOACP_560_20. Epub 2022 Jun 15.
citation: Unsal O, Seyhun N, Turk B, Ekici M, Dobrucali H, Turgut S. The Evaluation of Upper Airway Complications Secondary to Intubation: Cuff Pressure Manometer Versus Conventional Palpation Method. Sisli Etfal Hastan Tip Bul. 2018 Dec 28;52(4):289-295. doi: 10.5350/SEMB.20171214085933. eCollection 2018.