Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
76 participants
INTERVENTIONAL
2025-09-24
2026-02-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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ETT cuff pressure 0 mmHg
ETT cuff pressure will be set to 0 mmHg
ETT cuff pressure 0 mmHg
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
ETT cuff pressure will be set to 20-30 mmHg
ETT 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)
Interventions
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ETT cuff pressure 0 mmHg
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
In this group, the endotracheal tube (ETT) cuff pressure will be maintained at 20-30 mmHg during cardiopulmonary bypass (CPB)
Eligibility Criteria
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Inclusion Criteria
* Aged 18-80 years
* ASA physical status class III-IV
* Providing written informed consent
Exclusion Criteria
* Anatomical abnormalities of the upper airway
* Body mass index (BMI) \> 35 kg/m²
* Acute respiratory tract infection
* Emergency surgeries
18 Years
80 Years
ALL
No
Sponsors
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Engin Çetin
OTHER_GOV
Responsible Party
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Engin Çetin
principal investigator
Principal Investigators
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Engin Çetin
Role: PRINCIPAL_INVESTIGATOR
Kocaeli City Hospital
Locations
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University of Health Sciences Kocaeli City Hospital
İzmit, Kocaeli, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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KSH-ANREA-EC-03
Identifier Type: -
Identifier Source: org_study_id
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