Comparison of Different Methods for Determining Endotracheal Cuff Pressure

NCT06107998 | Completed

• 1 other identifier: SNR-10/143
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, General; Intubation, Intratracheal

Keywords

Cuff pressure; Endotracheal intubation; endotracheal tube; inflation; measurement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• endotracheal tube diameters

  After induction of anesthesia and intubation

• endotracheal tube brands

  After induction of anesthesia and intubation

Study Arms (2)

Stethoscope

EXPERIMENTAL

Patients whose endotracheal tube cuff is inflated via a stethoscope

Other: stethoscope

Audible leak/Balloon palpation

ACTIVE COMPARATOR

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

Other: Audible leak/Balloon palpation

Interventions

stethoscope OTHER

endotracheal tube cuff will be inflated via stethoscope guidance

Stethoscope

Audible leak/Balloon palpation OTHER

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

Audible leak/Balloon palpation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University

Isparta, Merkez, 32200, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 32198671 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.

  PMID: 32199655 BACKGROUND

• 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.

  PMID: 28764268 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.

  PMID: 36778817 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.

  PMID: 32774093 RESULT

MeSH Terms

Interventions

Stethoscopes

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies

Study Officials

• Mustafa Soner Özcan, M.D.

  Suleyman Demirel University,Faculty of Medicine, Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the person who intubates the patient and inflates the cuff using a method will know what the procedure is.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: October 30, 2023
• Study Start: November 2, 2023
• Primary Completion: December 29, 2023
• Study Completion: January 2, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)