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

Sponsor
Izmir Katip Celebi University
Study ID
NCT07341646
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Jan 14, 2026
Start date
Mar 1, 2026
Status verified
Jan 2026
Primary completion
Mar 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

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

Central Contacts

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