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

January 14, 2026 updated by: Ahmet Salih Tüzen, MD, Izmir Katip Celebi University

The Effect of Endotracheal Tube Cuff Pressure Assessment Methods on Postoperative Complications in Patients Undergoing Elective Breast Surgery: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, randomized, parallel-group, single-blind clinical trial investigates the efficacy of different endotracheal tube cuff pressure monitoring techniques in preventing postoperative airway morbidity. The study will be conducted at the İzmir Kâtip Çelebi University Atatürk Training and Research Hospital, Department of Anesthesiology and Reanimation.

The study population consists of female patients aged 18-65 years, classified as ASA I-III, who are scheduled for elective breast surgery under general anesthesia requiring endotracheal intubation. Breast surgery patients were selected as the target population because they represent a homogenous group (typically healthy females), undergo procedures of moderate duration (1-3 hours), and remain in a fixed supine position without significant head-neck manipulation, thereby minimizing confounding variables that could affect cuff pressure.

Study Procedures and Randomization: A total of 90 eligible patients will be enrolled. After providing informed consent, participants will be randomized into three groups with a 1:1:1 allocation ratio. Randomization will be performed using a computer-generated random sequence (via Research Randomizer, randomizer.org) to ensure unbiased assignment. The allocation sequence will be concealed from the investigators until the patient has been successfully intubated.

The three study arms are defined as follows:

  • Continuous Pressure Indicator Group: Cuff pressure will be continuously monitored and maintained within the therapeutic range of 20-30 cmH₂O using a continuous pressure indicator device throughout the surgery.
  • Manometer Group: Following intubation, the cuff pressure will be measured once using a manual manometer and adjusted to the 20-30 cmH₂O range. No further adjustments will be made unless clinically indicated.
  • Control Group (Minimal Occlusive Volume): The cuff will be inflated using the "minimal occlusive volume" technique, wherein the cuff is inflated with the minimum volume of air required to prevent audible air leaks. No objective pressure gauge will be used.

Anesthesia Protocol: All patients will receive a standardized anesthesia protocol. Induction will be achieved with appropriate intravenous agents, and intubation will be performed by the same experienced anesthesiologist to ensure consistency. Anesthesia maintenance will be uniform across all groups. The study excludes patients with a history of difficult intubation, recent respiratory tract infections (within 6 months), preoperative sore throat/hoarseness, or operative times exceeding 3 hours.

Data Collection and Outcomes: The primary outcome is the incidence and severity of postoperative sore throat. Secondary outcomes include hoarseness, cough, dysphagia, laringospasm/bronchospasm, hemorrhage, and recovery times (extubation time, time to spontaneous respiration, and PACU stay duration).

Outcomes will be assessed at four specific time points:

  • 0 hours (immediately post-extubation)
  • 1 hour (in the Post-Anesthesia Care Unit - PACU)
  • 12 hours (on the ward)
  • 24 hours (postoperative day 1)

A four-point scale (0-3) will be used to grade symptoms (e.g., 0=None, 1=Mild, 2=Moderate, 3=Severe). To ensure blinding, the postoperative symptom assessment will be performed by a researcher who is unaware of the patient's group assignment.

Statistical Analysis: Sample size calculation indicated that 81 patients are required to detect a significant difference (effect size f=0.41, power=0.90, alpha=0.05), which was increased to 90 to account for a 10% dropout rate. Data will be analyzed using SPSS 26.0. Continuous variables will be analyzed using ANOVA or Kruskal-Wallis tests depending on normality, and categorical variables will be analyzed using Chi-square or Fisher's exact tests. Repeated measures (time-dependent changes) will be analyzed using the Friedman test.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ahmet Salih Tüzen, M.D.
  • Phone Number: +90 535 391 55 77
  • Email: astuzen@icloud.com

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Karabaglar
      • Izmir, Karabaglar, Turkey (Türkiye), 35360
        • Izmir Katip Celebi University Ataturk Training and Research Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Senem Girgin, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous Pressure Indicator Group
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
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.
Other Names:
  • Continuous Cuff Pressure Controller
Active Comparator: Manometer Group
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
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.
Other Names:
  • Handheld Cuff Manometer
Active Comparator: Control Group (Minimal Occlusive Volume)
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
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.
Other Names:
  • Leak Test Method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and Severity of Postoperative Sore Throat
Time Frame: 4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Airway Hemorrhage
Time Frame: At the time of extubation
Presence of blood on the endotracheal tube or in the airway immediately following extubation (Yes/No).
At the time of extubation
Incidence and Severity of Hoarseness
Time Frame: 4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
Assessed using a 4-point scale: 0 = None; 1 = Mild (minimal change in speech); 2 = Moderate (obvious hoarseness, communication not affected); 3 = Severe (affects communication)
4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
Incidence and Severity of Cough
Time Frame: 4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
Assessed using a 4-point scale: 0 = None; 1 = Mild (occasional); 2 = Moderate (frequent, disturbing); 3 = Severe (uncontrolled, constant, painful).
4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
Incidence and Severity of Dysphagia
Time Frame: 4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
Difficulty swallowing assessed using a 4-point scale: 0 = None; 1 = Mild (mild difficulty with solid foods); 2 = Moderate (obvious difficulty with solids and liquids); 3 = Severe (limits oral intake).
4 time points: Baseline (post-extubation), 1st, 12th and 24th hour following extubation.
Incidence of Laryngospasm or Bronchospasm
Time Frame: Up to 30 minutes following extubation.
The presence (Yes) or absence (No) of laryngospasm or bronchospasm occurring during the extubation phase.
Up to 30 minutes following extubation.
Extubation Time
Time Frame: Up to 30 minutes following surgery completion.
The duration in minutes from the completion of the surgery to the removal of the endotracheal tube.
Up to 30 minutes following surgery completion.
Time to Spontaneous Respiration
Time Frame: Up to 30 minutes following extubation.
The time in minutes from the discontinuation of anesthetic agents to the return of adequate spontaneous ventilation.
Up to 30 minutes following extubation.
Early Recovery Time
Time Frame: Up to 30 minutes following extubation.
The time in minutes from extubation to the achievement of recovery criteria on the operating table (responding to verbal stimuli, head lift for 5 seconds, swallowing) prior to PACU transfer.
Up to 30 minutes following extubation.
Duration of Post-Anesthesia Care Unit (PACU) Stay
Time Frame: Up to 24 hours following extubation.
The total duration in minutes the patient remains in the recovery room until discharge criteria are met.
Up to 24 hours following extubation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Investigators

  • Principal Investigator: Murat Aksun, M.D., Izmir Katip Celebi University Ataturk Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Estimated)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-KAEK-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

All data necessary to support the study protocol, including de-identified individual participant data (IPD) related to study protocol, and primary and secondary outcome measures, will be made available upon reasonable request from qualified researchers for academic purposes, in accordance with institutional and ethical guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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