Cuff Pressure and Airway Edema in CABG With CPB

NCT07148024 | Completed

• 1 other identifier: KSH-ANREA-EC-03
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Airway Ultrasound; Airway Edema; Endotracheal Tube

Keywords

airway edema; coronary Bypass Greft Surgery; endotrecheal tube

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• ultrasonographic airway parameter -tongue width

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

• ultrasonographic airway parameter -tongue volume

  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

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

Study Arms (2)

ETT cuff pressure 0 mmHg

ACTIVE COMPARATOR

ETT cuff pressure will be set to 0 mmHg

Device: ETT cuff pressure 0 mmHg

ETT cuff pressure 20-30 mmHg

ACTIVE COMPARATOR

ETT cuff pressure will be set to 20-30 mmHg

Device: ETT cuff pressure 20-30 mmHg

Interventions

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 0 mmHg

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)

ETT cuff pressure 20-30 mmHg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Engin Çetin: lead

Study Sites (1)

University of Health Sciences Kocaeli City Hospital

İzmit, Kocaeli, 41200, Turkey (Türkiye)

Location

Related Publications (1)

• Aytac BG, Soyal OB. Ultrasonographic evaluation of the postoperative airway edema after robotic prostatectomy: a single center observational study. Eur Rev Med Pharmacol Sci. 2023 Sep;27(18):8505-8513. doi: 10.26355/eurrev_202309_33775.

  PMID: 37782166 BACKGROUND

Study Officials

• Engin Çetin

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: Parallel assigment

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 29, 2025
• Study Start: September 24, 2025
• Primary Completion: April 19, 2026
• Study Completion: April 19, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)