Cuff Pressure and Airway Edema in CABG With CPB

Engin Çetin

Status: Enrolling

Conditions: Endotracheal Tube; Airway Ultrasound; Airway Edema

Treatments: Device: ETT cuff pressure 20-30 mmHg; Device: ETT cuff pressure 0 mmHg

Study type: Interventional

Funder types: Other

Identifiers

NCT07148024

KSH-ANREA-EC-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for elective coronary artery bypass grafting (CABG) surgery
• Aged 18-80 years
• ASA physical status class III-IV
• Providing written informed consent

Exclusion criteria

• History of difficult intubation
• Anatomical abnormalities of the upper airway
• Body mass index (BMI) > 35 kg/m²
• Acute respiratory tract infection
• Emergency surgeries

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups

ETT cuff pressure 0 mmHg

Active Comparator group

Description:

ETT cuff pressure will be set to 0 mmHg

Treatment:

Device: ETT cuff pressure 0 mmHg

ETT cuff pressure 20-30 mmHg

Active Comparator group

Description:

ETT cuff pressure will be set to 20-30 mmHg

Treatment:

Device: ETT cuff pressure 20-30 mmHg