Effect of Cuff Pressure Assessment Methods on Postoperative Complications in Breast Surgery

NCT07341646 | Not Yet Recruiting

• 1 other identifier: 2025-KAEK-23
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Endotracheal intubation is a standard procedure used to secure the airway during general anesthesia. A key component of the breathing tube is the "cuff," a balloon-like device that is inflated to seal the airway and prevent aspiration. However, if the pressure within this cuff is too high, it can restrict blood flow to the tracheal lining, leading to complications such as postoperative sore throat, hoarseness, and difficulty swallowing (dysphagia). Currently, there are various methods to monitor and adjust this pressure. In many clinical practices, the pressure is adjusted subjectively or checked only once at the beginning of the surgery. These methods may allow pressure to exceed safe limits (typically 20-30 cmH₂O) or fluctuate during the procedure, potentially causing tissue irritation. This randomized controlled trial aims to compare three different methods of assessing and maintaining endotracheal tube cuff pressure to determine which is most effective at reducing postoperative complications. The study focuses on women undergoing elective breast surgery, a group chosen because the surgery typically lasts 1-3 hours and does not involve major changes in head and neck position, allowing for a clear assessment of the cuff pressure methods. Participants will be randomly assigned to one of three groups:

• Continuous Monitoring Group: Cuff pressure is monitored continuously using a pressure indicator and maintained within the 20-30 cmH₂O range throughout the surgery.
• Manometer Group: Cuff pressure is measured and set to 20-30 cmH₂O using a manual manometer once, immediately after intubation.
• Control Group (Minimal Occlusive Volume): The cuff is inflated with the minimum amount of air required to prevent an air leak, without using a pressure gauge. Researchers will assess patients for sore throat, cough, hoarseness, and swallowing difficulties at 0, 1, 12, and 24 hours after surgery to identify the safest and most comfortable method for airway management.

Conditions

Airway Complications; Postoperative Sore Throat; Hoarseness; Dysphagia; Cough Severity

Keywords

Continuous Cuff Pressure Monitoring; Manometer; Endotracheal Tube Cuff Pressure; Postoperative Sore Throat; Airway Complications; Intubation Safety

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Postoperative Sore Throat

  Postoperative sore throat will be assessed using a 4-point categorical scale. The scoring is defined as follows: 0 = No sore throat; 1 = Mild sore throat (less than a cold); 2 = Moderate sore throat (similar to a cold); 3 = Severe sore throat (worse than a cold). Higher scores indicate a more severe adverse outcome.

  4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.

Secondary Outcomes (9)

• Incidence and Severity of Hoarseness

  4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.

• Incidence and Severity of Cough

  4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.

• Incidence and Severity of Dysphagia

  4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.

• Incidence of Laryngospasm or Bronchospasm

  Up to 30 minutes following extubation.

• Incidence of Airway Hemorrhage

  At the time of extubation

Study Arms (3)

Continuous Pressure Indicator Group

EXPERIMENTAL

Patients in this group will have their endotracheal tube cuff pressure continuously monitored and maintained within the range of 20-30 cmH₂O using a continuous pressure indicator device throughout the surgery.

Device: Continuous Cuff Pressure Indicator

Manometer Group

ACTIVE COMPARATOR

Patients in this group will have their endotracheal tube cuff pressure measured and adjusted once using a manual manometer immediately after intubation to a target range of 20-30 cmH₂O.

Device: Manual Cuff Pressure Manometer

Control Group (Minimal Occlusive Volume)

ACTIVE COMPARATOR

Patients in this group will have their endotracheal tube cuff inflated using the minimal occlusive volume technique (inflating until the air leak stops) without the use of a pressure gauge.

Procedure: Minimal Occlusive Volume Technique

Interventions

Continuous Cuff Pressure Indicator DEVICE

A device utilized to continuously monitor the endotracheal tube cuff pressure intraoperatively. It allows for real-time observation and maintenance of the pressure within the target range of 20-30 cmH₂O throughout the surgery.

Also known as: Continuous Cuff Pressure Controller

Continuous Pressure Indicator Group

Manual Cuff Pressure Manometer DEVICE

A standard analog manometer used for a single-time measurement of the endotracheal tube cuff pressure immediately after intubation. The pressure is adjusted to the standard range of 20-30 cmH₂O and not monitored continuously thereafter.

Also known as: Handheld Cuff Manometer

Manometer Group

Minimal Occlusive Volume Technique PROCEDURE

A standard clinical technique where the endotracheal tube cuff is inflated with the minimum volume of air required to prevent audible air leakage during positive pressure ventilation. No objective pressure gauge is used for adjustment.

Also known as: Leak Test Method

Control Group (Minimal Occlusive Volume)

Eligibility Criteria

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

You may qualify if:

• Female patients aged 18 to 65 years.
• Patients classified as American Society of Anesthesiologists (ASA) physical status I, II, or III.
• Patients scheduled for elective breast surgery requiring general anesthesia and endotracheal intubation.
• Patients who provide voluntary written informed consent to participate.

You may not qualify if:

• Patients with a history of Chronic Obstructive Pulmonary Disease (COPD) or an asthma attack within the last 6 months.
• Presence of preoperative sore throat, hoarseness, or cough.
• Patients with predicted difficult intubation or those who are difficult to intubate.
• Patients with communication difficulties that prevent accurate assessment of symptoms.
• Patients whose surgery duration exceeds 3 hours.
• Patients older than 65 years.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University Atatürk Training and Research Hospital

Izmir, Karabaglar, 35360, Turkey (Türkiye)

Location

Related Publications (6)

• Wang C, Yan X, Gao C, Liu S, Bao D, Zhang D, Jiang J, Wu A. Effect of continuous measurement and adjustment of endotracheal tube cuff pressure on postoperative sore throat in patients undergoing gynecological laparoscopic surgery: a randomized controlled trial. J Clin Monit Comput. 2024 Dec;38(6):1379-1386. doi: 10.1007/s10877-024-01173-y. Epub 2024 May 11.

  PMID: 38733506 RESULT

• Nwosu ADG, Ossai EN, Ejezie C, Obodo OC. Educational Intervention Can Improve the Pilot Balloon Palpation Method of Tracheal Tube Cuff Pressure Monitoring: An Experimental Study. J West Afr Coll Surg. 2025 Jan-Mar;15(1):53-58. doi: 10.4103/jwas.jwas_162_23. Epub 2024 Aug 2.

  PMID: 39735817 RESULT

• Maertens B, Blot K, Blot S. Prevention of Ventilator-Associated and Early Postoperative Pneumonia Through Tapered Endotracheal Tube Cuffs: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Crit Care Med. 2018 Feb;46(2):316-323. doi: 10.1097/CCM.0000000000002889.

  PMID: 29206767 RESULT

• Vasanth Karthik R, Ranganathan P, Kulkarni AP, Sharma KS. Does cuff pressure monitoring reduce postoperative pharyngolaryngeal adverse events after LMA-ProSeal insertion? A parallel group randomised trial. J Anesth. 2014 Oct;28(5):662-7. doi: 10.1007/s00540-014-1811-0. Epub 2014 Mar 19.

  PMID: 24643810 RESULT

• Choi HR, Kim S, Kim HJ, Ahn EJ, Kim KW, Bang SR. [Endotracheal tube cuff pressure increases in patients undergoing shoulder arthroscopy: a single cohort study]. Braz J Anesthesiol. 2020 Nov-Dec;70(6):583-587. doi: 10.1016/j.bjan.2020.04.021. Epub 2020 Nov 18.

  PMID: 33279230 RESULT

• El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.

  PMID: 27158989 RESULT

MeSH Terms

Conditions

Hoarseness; Deglutition Disorders

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases

Study Officials

• Murat Aksun, M.D.

  Izmir Katip Celebi University Atatürk Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murat Aksun, M.D.

CONTACT

+90 552 363 16 14; murataksun@yahoo.com

Ahmet Salih Tüzen, M.D.

CONTACT

+90 535 391 55 77; astuzen@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the distinct physical differences between the devices and techniques used (continuous pressure indicator, manual manometer, or standard syringe), the anesthesiologist performing the intubation and cuff pressure adjustment cannot be blinded to the group assignment. However, to ensure study integrity, the outcome assessors responsible for collecting postoperative data and scoring symptoms (sore throat, hoarseness, dysphagia, etc.) at 0, 1, 12, and 24 hours will be strictly blinded to the patient's allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: This study utilizes a parallel-group design with a 1:1:1 allocation ratio. Participants are randomized into three distinct arms: continuous pressure monitoring, intermittent manometer measurement, and a control group utilizing the minimal occlusive volume technique. The study employs a single-blind masking protocol wherein the outcomes assessor is blinded to the intervention assignment to minimize detection bias. This model is designed to compare the efficacy of objective versus subjective cuff pressure management strategies in preventing postoperative upper airway complications within a homogenous population of elective breast surgery patients.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

TU (1)