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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:
Researchers will compare ''stethoscope'' and ''audible leak/balloon palpation'' groups to see if which method is effective like a manometer.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stethoscope | Experimental | Patients whose endotracheal tube cuff is inflated via a stethoscope |
|
| Audible leak/Balloon palpation | Active Comparator | Patients whose endotracheal tube cuff is inflated via audible leak/balloon palpation method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stethoscope | Other | endotracheal tube cuff will be inflated via stethoscope guidance |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mustafa Soner Özcan, M.D. | Suleyman Demirel University,Faculty of Medicine, Department of Anesthesiology and Reanimation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suleyman Demirel University | Isparta | Merkez | 32200 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32198671 | Background | 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. | |
| 32199655 | Background | 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. |
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After the study is finished, data from the study will be shared when reasonable reasons are presented.
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| ID | Term |
|---|---|
| D019023 | Stethoscopes |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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Only the person who intubates the patient and inflates the cuff using a method will know what the procedure is.
| Audible leak/Balloon palpation |
| Other |
endotracheal tube cuff will be inflated via audible leak/balloon palpation method |
|
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 |
| 28764268 | Result | 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. |
| 36778817 | Result | 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. |
| 32774093 | Result | 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. |