NCT07148024

Cuff Pressure and Airway Edema in CABG With CPB

Effects of Endotracheal Tube Cuff Pressure Management on Upper Airway Edema During Cardiopulmonary Bypass in Coronary Artery Bypass Grafting: A Double-Blind, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Engin Çetin · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study investigates how endotracheal tube (ETT) cuff pressure management during cardiopulmonary bypass (CPB) in coronary artery bypass grafting (CABG) affects upper airway edema. Patients will be randomized into two groups: cuff pressure kept at 0 mmHg or maintained at 20-30 mmHg during CPB. Ultrasonography will be used to measure lateral pharyngeal wall thickness, tongue parameters, and other airway dimensions at predefined perioperative time points. The primary outcome is the change in lateral pharyngeal wall thickness as an indicator of airway edema. A total of 76 patients aged 18-80 years undergoing elective CABG with CPB will be enrolled. The results aim to clarify safe cuff pressure management strategies to reduce airway edema.

Detailed description

Purpose This study aims to evaluate the effect of endotracheal tube (ETT) cuff pressure management during cardiopulmonary bypass (CPB) in coronary artery bypass grafting (CABG) surgery on the development of upper airway edema. Ultrasonography will be used to assess changes in lateral pharyngeal wall (LPW) thickness, tongue thickness, correlation between intravenous fluid volume at multiple perioperative time points. Study Design This is a prospective, randomized, double-blind, controlled clinical trial. Patients undergoing elective CABG with CPB will be randomly assigned into two groups: Group 1: ETT cuff pressure maintained at 0 mmHg during CPB Group 2: ETT cuff pressure maintained at 20-30 mmHg during CPB Cuff pressures will be monitored with a manometer every 5 minutes and adjusted as needed. At the end of CPB, all patients will have standard cuff pressure (20-30 mmHg). Outcomes Primary outcome: Changes in LPW thickness as a marker of upper airway edema assessed by ultrasonography at five time points (T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour). Secondary outcomes: Changes in tongue thickness, correlation between intravenous fluid volume and airway edema. Participation Approximately 76 patients (18-80 years, ASA III-IV) scheduled for elective CABG with CPB will be enrolled.

Conditions

• Airway Ultrasound
• Airway Edema
• Endotracheal Tube

Interventions

Type	Name	Description
DEVICE	ETT cuff pressure 0 mmHg	In this group, the endotracheal tube (ETT) cuff pressure will be maintained at 0 mmHg during cardiopulmonary bypass (CPB)
DEVICE	ETT cuff pressure 20-30 mmHg	In this group, the endotracheal tube (ETT) cuff pressure will be maintained at 20-30 mmHg during cardiopulmonary bypass (CPB)

Timeline

• Start date: 2025-09-24
• Primary completion: 2026-02-01
• Completion: 2026-02-10
• First posted: 2025-08-29
• Last updated: 2026-01-08

Locations

1 site across 1 country: Turkey (Türkiye)