Airway Edema, Airway Ultrasound, Endotracheal Tube
Conditions
Keywords
airway edema, coronary Bypass Greft Surgery, endotrecheal tube
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.
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.
Interventions
DEVICEETT cuff pressure 0 mmHg
In this group, the endotracheal tube (ETT) cuff pressure will be maintained at 0 mmHg during cardiopulmonary bypass (CPB)
DEVICEETT 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)
Sponsors
Engin Çetin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Parallel assigment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lateral Pharyngeal Wall Thickness Measured by Airway Ultrasound | 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
| Measure | Time frame | Description |
|---|---|---|
| ultrasonographic airway parameter -tongue width | 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 |
| ultrasonographic airway parameter -tongue volume | 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) |
| 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 | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATOREngin Çetin
Kocaeli City Hospital
Outcome results
None listed