Airway UltrasoundNCT07148024
Cuff Pressure and Airway Edema in CABG With CPB
A study testing ETT cuff pressure 0 mmHg and ETT cuff pressure 20-30 mmHg in people with Airway Ultrasound and Airway Edema, run by Engin Çetin at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Airway Ultrasound, Airway Edema, Endotracheal Tube
- What is being tested?
- ETT cuff pressure 0 mmHg and ETT cuff pressure 20-30 mmHg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Sep 2025to 19 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective coronary artery bypass grafting (CABG) surgery
- Aged 18-80 years
- ASA physical status class III-IV
- Providing written informed consent
Who cannot join
- History of difficult intubation
- Anatomical abnormalities of the upper airway
- Body mass index (BMI) > 35 kg/m²
- Acute respiratory tract infection
- Emergency surgeries
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Kocaeli City Hospital
Kocaeli
About this study
Official 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
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.
Read the 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.
- Conditions
- Airway Ultrasound, Airway Edema, Endotracheal Tube
- Being tested
- ETT cuff pressure 0 mmHg, ETT cuff pressure 20-30 mmHg
- Keywords
- airway edema, coronary Bypass Greft Surgery, endotrecheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETT cuff pressure 0 mmHgDevice
In this group, the endotracheal tube (ETT) cuff pressure will be maintained at 0 mmHg during cardiopulmonary bypass (CPB)
ETT cuff pressure 20-30 mmHgDevice
In this group, the endotracheal tube (ETT) cuff pressure will be maintained at 20-30 mmHg during cardiopulmonary bypass (CPB)
| Study group | Role | What they receive |
|---|---|---|
| ETT cuff pressure 0 mmHg | Active comparator | ETT cuff pressure will be set to 0 mmHg Receives: Device: ETT cuff pressure 0 mmHg |
| ETT cuff pressure 20-30 mmHg | Active comparator | ETT cuff pressure will be set to 20-30 mmHg Receives: Device: ETT cuff pressure 20-30 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour
ultrasonographic airway parameter -tongue volume
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)
Measured: 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
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.
Measured: T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start24 Sep 2025
- Primary completion19 Apr 2026
- Study completion19 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assigment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Engin Çetin
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Engin Çetin, Kocaeli City Hospital
- Investigators
- Engin Çetin, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148024
- Sponsor's protocol ID
- KSH-ANREA-EC-03
- Status last verified
- Jul 2026
- First submitted
- 21 Aug 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37782166
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07148024
- Acronym / sponsor ID
- KSH-ANREA-EC-03
- Conditions
- Airway Ultrasound, Airway Edema, Endotracheal Tube
- Keywords
- airway edema, coronary Bypass Greft Surgery, endotrecheal tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Engin ÇetinOther government
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 19 Apr 2026 (actual)
- Study completion
- 19 Apr 2026 (actual)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assigment
| Arm | Type | Receives |
|---|---|---|
| ETT cuff pressure 0 mmHg | Active comparator | Device: ETT cuff pressure 0 mmHgETT cuff pressure will be set to 0 mmHg |
| ETT cuff pressure 20-30 mmHg | Active comparator | Device: ETT cuff pressure 20-30 mmHgETT cuff pressure will be set to 20-30 mmHg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for elective coronary artery bypass grafting (CABG) surgery
- Aged 18-80 years
- ASA physical status class III-IV
- Providing written informed consent
Key exclusion criteria (5 listed)
- History of difficult intubation
- Anatomical abnormalities of the upper airway
- Body mass index (BMI) > 35 kg/m²
- Acute respiratory tract infection
- Emergency surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ETT cuff pressure 0 mmHgIn this group, the endotracheal tube (ETT) cuff pressure will be maintained at 0 mmHg during cardiopulmonary bypass (CPB) | Device | ETT cuff pressure 0 mmHg |
| ETT cuff pressure 20-30 mmHgIn this group, the endotracheal tube (ETT) cuff pressure will be maintained at 20-30 mmHg during cardiopulmonary bypass (CPB) | Device | ETT cuff pressure 20-30 mmHg |
Primary outcome
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.
3 secondary outcomes
ultrasonographic airway parameter -tongue width
Time frame: T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour
ultrasonographic airway parameter -tongue volume
Time frame: 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
Time frame: T0: Preoperative T1: Before initiation of CPB T2: At the end of CPB T3: 2nd postoperative hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 37782166Aytac 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Engin Çetin principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETT cuff pressure 0 mmHg and ETT cuff pressure 20-30 mmHg in people with Airway Ultrasound and Airway Edema, run by Engin Çetin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07148024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.