Peep Titration in Lung Protective VentilationNCT07044089
Lung Protective Ventilation and Driving Pressure Guided PEEP Titration in CABG Surgery
An observational study of Peep Titration in Lung Protective Ventilation, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Our aim in this study is to compare fixed and individualized PEEP (driving pressure guided ) application for intraoperative lung protective ventilation in patients undergoing on-pump CABG surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Peep Titration in Lung Protective Ventilation
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jul 2025to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who will undergo elective on-pump coronary artery bypass graft surgery under general anesthesia
Who may be able to join
- Patients scheduled for elective on-pump coronary artery bypass graft surgery via median sternotomy
- Patients between the ages of 18 and 70
- ASA (American Society of Anesthesiologists) physical status classification II-III
Who cannot join
- Patients with an ejection fraction below 35%
- Patients who did not consent to participate in the study
- Patients undergoing emergency surgery
- Patients who are allergic to the anesthetic drugs used
- Patients who have undergone lung resection
- Those with a history of mechanical ventilation in the 2 months before surgery
Show all 14Show fewer
- Patients who have undergone total circulatory arrest and deep hypothermia
- Patients with obstructive sleep apnea syndrome requiring long-term ventilation assistance
- Morbid obesity (Body Mass Index>35kg/m2)
- Patients with refractory hypoxemia (arterial oxygen saturation below 88% despite 100% oxygen inhalation)
- COPD (FEV1<70%)
- Patients with chronic renal failure (serum creatine>1.8 mg/dl)
- Anemia (Hg<10 gr/dl)
- Patients who have had an intraaortic balloon pump placed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli University Faculty of Medicine
Kocaeli, Izmit, 41100
Zeynep Açık, 05077367990, zeynebacik96@gmail.com
About this study
Official title: Comparison of Individualized PEEP Application Versus Fixed PEEP Application for Lung-Protective Ventilation in Patients Undergoing On-Pump Coronary Artery Bypass Grafting Surgery
Our aim in this study is to compare fixed and individualized PEEP (driving pressure guided ) application for intraoperative lung protective ventilation in patients undergoing on-pump CABG surgery.
Researcher aimed to compare the effects of two different PEEP application methods on intraoperative hemodynamics, respiratory mechanics, and gas exchange, as well as postoperative extubation times, respiratory complications (atelectasis, need for non invasive mechanical ventilatıon, need for re-entubatıon) length of stay in the intensive care unit, and discharge times.
Read the detailed description
The primary goal of the researchers: To compare the effects of fixed PEEP versus driving pressure guided individualized PEEP in lung protective mechanical ventilation during on-pump open heart surgery effect of PaO2/ FiO2 ratio end of surgery.
The secondary goals of the researchers: To compare intraoperative hemodynamics, lung compliance and airway pressures, extubation time and respiratory complications [development of atelectasis, need for noninvasive mechanical ventilation (high-flow nasal cannula or CPAP application), need for re-intubation], length of stay in the ICU and discharge times.
- Keywords
- Lung Protective Ventilation, Fixed PEEP, Individualized PEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fixed PEEP | Not described | |
| Indıvıdalızed PEEP | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on intraoperative oxygenation, hemodynamics, lung compliance and airway pressures
Data will be recorded during surgery and the first 24 hours after extubation.
Measured: First one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start23 Jul 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peep Titration in Lung Protective VentilationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep AÇIK, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044089
- Sponsor's protocol ID
- KAEK/05.b1.01
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Individualized PEEP Application Versus Fixed PEEP Application for Lung-Protective Ventilation in Patients Undergoing On-Pump Coronary Artery Bypass Grafting Surgery
- ClinicalTrials.gov ID
- NCT07044089
- Acronym / sponsor ID
- KAEK/05.b1.01
- Keywords
- Lung Protective Ventilation, Fixed PEEP, Individualized PEEP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 29 Jun 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.
Our aim in this study is to compare fixed and individualized PEEP (driving pressure guided ) application for intraoperative lung protective ventilation in patients undergoing on-pump CABG surgery.
Researcher aimed to compare the effects of two different PEEP application methods on intraoperative hemodynamics, respiratory mechanics, and gas exchange, as well as postoperative extubation times, respiratory complications (atelectasis, need for non invasive mechanical ventilatıon, need for re-entubatıon) length of stay in the intensive care unit, and discharge times.
Detailed description
The primary goal of the researchers: To compare the effects of fixed PEEP versus driving pressure guided individualized PEEP in lung protective mechanical ventilation during on-pump open heart surgery effect of PaO2/ FiO2 ratio end of surgery.
The secondary goals of the researchers: To compare intraoperative hemodynamics, lung compliance and airway pressures, extubation time and respiratory complications [development of atelectasis, need for noninvasive mechanical ventilation (high-flow nasal cannula or CPAP application), need for re-intubation], length of stay in the ICU and discharge times.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed PEEP | – | – |
| Indıvıdalızed PEEP | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo elective on-pump coronary artery bypass graft surgery under general anesthesia
Key inclusion criteria (3 listed)
- Patients scheduled for elective on-pump coronary artery bypass graft surgery via median sternotomy
- Patients between the ages of 18 and 70
- ASA (American Society of Anesthesiologists) physical status classification II-III
Key exclusion criteria (14 listed)
- Patients with an ejection fraction below 35%
- Patients who did not consent to participate in the study
- Patients undergoing emergency surgery
- Patients who are allergic to the anesthetic drugs used
- Patients who have undergone lung resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effects on intraoperative oxygenation, hemodynamics, lung compliance and airway pressures
Time frame: First one day
Data will be recorded during surgery and the first 24 hours after extubation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peep Titration in Lung Protective Ventilation, run by Kocaeli University 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 3 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 3 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Açık, MD (+905077367990, zeynebacik96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on intraoperative oxygenation, hemodynamics, lung compliance and airway pressures (time frame: First one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.