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NCT Number: NCT07148024

Cuff Pressure and Airway Edema in CABG With CPB

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Kocaeli City Hospital

Kocaeli, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ETT cuff pressure 0 mmHg

Device

In this group, the endotracheal tube (ETT) cuff pressure will be maintained at 0 mmHg during cardiopulmonary bypass (CPB)

ETT cuff pressure 20-30 mmHg

Device

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

Primary outcomes

  1. Change in Lateral Pharyngeal Wall Thickness Measured by Airway Ultrasound

    Time frame: T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour

    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.

Secondary outcomes

  1. ultrasonographic airway parameter -tongue width

    Time frame: T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour

    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

  2. ultrasonographic airway parameter -tongue volume

    Time frame: T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour

    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)

  3. Correlation Between Intravenous Fluid Volume and Airway Edema

    Time frame: T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour

    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.

Sponsors and collaborators

Lead sponsor

Engin Çetin

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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