NCT07341646

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

Not yet recruiting NA Last updated 15 January 2026

What this trial tests

NA trial testing Continuous Cuff Pressure Indicator in Airway Complications in 90 participants. Not yet recruiting.

Timeline

1 March 2026

Primary endpoint
1 March 2027

1 June 2027

Quick facts

Lead sponsor	Izmir Katip Celebi University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	90
Start date	1 March 2026
Primary completion	1 March 2027
Estimated completion	1 June 2027
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Continuous Cuff Pressure Indicator
• Manual Cuff Pressure Manometer
• Minimal Occlusive Volume Technique

Conditions studied

• Airway Complications — all drugs for Airway Complications →
• Postoperative Sore Throat — all drugs for Postoperative Sore Throat →
• Hoarseness — all drugs for Hoarseness →
• Dysphagia — all drugs for Dysphagia →

Sponsor

Izmir Katip Celebi University

Who can join

Adults 18 to 65, female only, with Airway Complications or Postoperative Sore Throat. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.