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

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Conditions studied: Airway Complications, Postoperative Sore Throat, Hoarseness, Dysphagia, Cough Severity

In brief

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 facts

Study ID: NCT07341646
Run by: Izmir Katip Celebi University
People needed: 90
Starts: 2026-03-01
Expected to finish: 2027-06-01
Last updated by the study team: 2026-01-15

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

Izmir Katip Celebi University Atatürk Training and Research Hospital — Izmir, Karabaglar, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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