An interventional study of ETT cuff pressure 0 mmHg and ETT cuff pressure 20-30 mmHg in Airway Ultrasound, Airway Edema and Endotracheal Tube, sponsored by Engin Çetin. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Engin Çetin · Not applicable, Interventional, and Diagnostic
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.
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.
Exclusion Criteria:
ETT cuff pressure will be set to 0 mmHg
Device: ETT cuff pressure 0 mmHg
ETT cuff pressure will be set to 20-30 mmHg
Device: ETT cuff pressure 20-30 mmHg
In this group, the endotracheal tube (ETT) cuff pressure will be maintained at 0 mmHg during cardiopulmonary bypass (CPB)
In this group, the endotracheal tube (ETT) cuff pressure will be maintained at 20-30 mmHg during cardiopulmonary bypass (CPB)
Change in Lateral Pharyngeal Wall Thickness Measured by Airway Ultrasound
To compare the effect of two different endotracheal tube (ETT) cuff pressures (0 mmHg vs. 20-30 mmHg) during cardiopulmonary bypass (CPB) in coronary artery bypass grafting (CABG) on upper airway edema. The degree of airway edema will be assessed by measuring changes in lateral pharyngeal wall thickness (in millimeters, mm) using ultrasound at predefined perioperative time points.
Time frame: T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour
ultrasonographic airway parameter -tongue width
To compare the effects of two different endotracheal tube (ETT) cuff pressures (0 mmHg vs. 20-30 mmHg) during cardiopulmonary bypass (CPB) in coronary artery bypass grafting (CABG) on upper airway edema. The degree of edema will be assessed by changes in ultrasonographic airway parameter, specifically tongue width (mm), measured before and after the procedure
Time frame: T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour
ultrasonographic airway parameter -tongue volume
To compare the effects of two different endotracheal tube (ETT) cuff pressures (0 mmHg vs. 20-30 mmHg) during cardiopulmonary bypass (CPB) in coronary artery bypass grafting (CABG) on the development of upper airway edema, which will be assessed by ultrasonographic measurements of upper airway structures before and after the procedure, including tongue thickness (mm).Tongue thickness (millimeters, mm)
Time frame: T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour
Correlation Between Intravenous Fluid Volume and Airway Edema
To evaluate the correlation between the total intravenous fluid volume administered intraoperatively and the degree of airway edema, as measured by changes in ultrasonographic airway parameters (e.g., tongue thickness, pharyngeal wall thickness) at defined time points.
Time frame: T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour
Plan to share: No
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