Postoperative Pulmonary ComplicationsMP-CABGNCT07639489
Mechanical Power and Pulmonary Complications in CABG Surgery
An observational study of Postoperative Pulmonary Complications and Coronary Artery Bypass Graft Surgery (CABG), run by Fusun Gozen at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluates the association between intraoperative mechanical power (MP) - a composite measure of the total energy delivered to the lungs during mechanical ventilation - and postoperative pulmonary complications (PPCs) and prolonged mechanical ventilation in adult patients undergoing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Complications, Coronary Artery Bypass Graft Surgery (CABG), Prolonged Mechanical Ventilation
- What is being tested?
- Intraoperative Mechanical Ventilation Monitoring
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2026to Sep 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective isolated CABG surgery with cardiopulmonary bypass at a single tertiary cardiac surgery center
Who may be able to join
- Age 18 years or older
- Scheduled for elective, first-time isolated CABG surgery
- Use of cardiopulmonary bypass (CPB)
- Intraoperative mechanical ventilation applied under general anesthesia with recordable ventilator data
- Provision of written informed consent
Who cannot join
- Emergency cardiac surgery
- Off-pump CABG (without CPB)
- Preoperative requirement for invasive mechanical ventilation
- Advanced chronic lung disease
- Incomplete or unreliable intraoperative ventilatory data
- Intraoperative use of advanced non-standard support (ECMO)
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
Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye
Bursa
About this study
Official title: Association of Intraoperative Mechanical Power With Postoperative Pulmonary Complications and Prolonged Mechanical Ventilation in Coronary Artery Bypass Graft Surgery
This prospective observational study evaluates the association between intraoperative mechanical power (MP) - a composite measure of the total energy delivered to the lungs during mechanical ventilation - and postoperative pulmonary complications (PPCs) and prolonged mechanical ventilation in adult patients undergoing elective coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB). Intraoperative ventilatory parameters including tidal volume, respiratory rate, airway pressures, and PEEP will be recorded and used to calculate MP and driving pressure (DP). No additional interventions will be applied beyond standard clinical care.
Read the detailed description
This single-center prospective observational study enrolls adult patients undergoing elective first-time isolated coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB).
Mechanical power (MP) will be calculated as: MP = 0.098 × RR
× VT × [PIP - 0.5 × (Pplat - PEEP)], normalized to predicted body weight (norMP = MP/PBW). Male PBW (kg) = 50 + 0.91 × [height (cm) - 152.4]; female PBW (kg) = 45.5 + 0.91 × [height (cm) - 152.4]. Driving pressure (DP) = Pplat - PEEP.
Ventilatory parameters (VT, RR, peak pressure, plateau pressure, PEEP, FiO2, EtCO2) and arterial blood gases (PaO2/FiO2, PaCO2, lactate) will be recorded at four standardized time points: T1 (post-intubation), T2 (post- sternotomy), T3 (pre-bypass), and T4 (post-bypass). No additional interventions beyond standard clinical care will be applied.
Postoperative outcomes including atelectasis, pneumonia, pleural effusion, prolonged oxygen requirement, need for non-invasive ventilation, re-intubation, duration of mechanical ventilation, and ICU length of stay will be assessed within the first 48 hours.
Sample size: 110 patients (α=0.05, power=80%, expected PPC incidence 35% vs 65% in low vs high MP groups, 20% dropout allowance). Statistical analysis will include Mann-Whitney U or t-test, chi-square or Fisher exact test, and logistic regression. Significance: p<0.05 (two-tailed).
- Conditions
- Postoperative Pulmonary Complications, Coronary Artery Bypass Graft Surgery (CABG), Prolonged Mechanical Ventilation
- Being tested
- Intraoperative Mechanical Ventilation Monitoring
- Keywords
- intraoperative ventilation, lung-protective ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Mechanical Ventilation MonitoringOther
Intraoperative ventilatory parameters (tidal volume, respiratory rate, plateau pressure, PEEP) are routinely recorded during CABG surgery. Mechanical power and driving pressure are calculated from these parameters. No additional intervention is applied beyond standard clinical care.
| Study group | Role | What they receive |
|---|---|---|
| CABG Patients | Adult patients undergoing elective isolated CABG surgery with cardiopulmonary bypass. Intraoperative ventilatory parameters will be recorded to calculate mechanical power and driving pressure. Receives: Other: Intraoperative Mechanical Ventilation Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pulmonary Complication
Occurrence of at least one of the following within the first 48 hours postoperatively: atelectasis, pleural effusion, pneumonia, prolonged oxygen requirement, need for non-invasive ventilation (NIV), or re-intubation
Measured: Within the first 48 hours postoperatively
Secondary outcomes (1)
Prolonged Mechanical Ventilation
Duration of mechanical ventilation greater than 24 hours
Measured: Up to 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary ComplicationsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fusun Gozen
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Fusun Gozen, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639489
- Sponsor's protocol ID
- 2024-TBEK 2026/01-18
- Other IDs
- 2024-TBEK 2026/01-18
- Acronym
- MP-CABG
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. This is a single-center observational study conducted at a public hospital. Data sharing is not planned due to institutional privacy regulations and the absence of external funding requiring data sharing.
Publications
Elefterion B, Cirenei C, Kipnis E, Cailliau E, Bruandet A, Tavernier B, Lamer A, Lebuffe G. Intraoperative Mechanical Power and Postoperative Pulmonary Complications in Noncardiothoracic Elective Surgery Patients: A 10-Year Retrospective Cohort Study. Anesthesiology. 2024 Mar 1;140(3):399-408. doi: 10.1097/ALN.0000000000004848.
PubMed 38011027Schuijt MTU, Hol L, Nijbroek SG, Ahuja S, van Meenen D, Mazzinari G, Hemmes S, Bluth T, Ball L, Gama-de Abreu M, Pelosi P, Schultz MJ, Serpa Neto A. Associations of dynamic driving pressure and mechanical power with postoperative pulmonary complications-posthoc analysis of two randomised clinical trials in open abdominal surgery. EClinicalMedicine. 2022 Apr 16;47:101397. doi: 10.1016/j.eclinm.2022.101397. eCollection 2022 May.
PubMed 35480074Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.
PubMed 34597688Zhu Y, Peng W, Zhen S, Jiang X. Mechanical power normalized to predicted body weight is associated with mortality in critically ill patients: a cohort study. BMC Anesthesiol. 2021 Nov 10;21(1):278. doi: 10.1186/s12871-021-01497-1.
PubMed 34753416Li T, Zhailauova A, Wachruschew I, Kuanyshbek A, Tulegenov S, Bukirova P, Zhakupbekov B, Nikitin I, Ayaganov D, Kapyshev T, Samalavicius R, Melnikov AL, Aslanidis T. Impact of Ventilation Discontinuation During Cardiopulmonary Bypass: A Prospective Observational Study. J Clin Med. 2025 Nov 19;14(22):8215. doi: 10.3390/jcm14228215.
PubMed 41303250Tonetti T, Vasques F, Rapetti F, Maiolo G, Collino F, Romitti F, Camporota L, Cressoni M, Cadringher P, Quintel M, Gattinoni L. Driving pressure and mechanical power: new targets for VILI prevention. Ann Transl Med. 2017 Jul;5(14):286. doi: 10.21037/atm.2017.07.08.
PubMed 28828361
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Intraoperative Mechanical Power With Postoperative Pulmonary Complications and Prolonged Mechanical Ventilation in Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT07639489
- Acronym / sponsor ID
- MP-CABG / 2024-TBEK 2026/01-18
- Conditions
- Postoperative Pulmonary Complications, Coronary Artery Bypass Graft Surgery (CABG), Prolonged Mechanical Ventilation
- Keywords
- intraoperative ventilation, lung-protective ventilation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Fusun GozenOther government
- Study start
- Jun 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 10 Jun 2026 (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 prospective observational study evaluates the association between intraoperative mechanical power (MP) - a composite measure of the total energy delivered to the lungs during mechanical ventilation - and postoperative pulmonary complications (PPCs) and prolonged mechanical ventilation in adult patients undergoing elective coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB). Intraoperative ventilatory parameters including tidal volume, respiratory rate, airway pressures, and PEEP will be recorded and used to calculate MP and driving pressure (DP). No additional interventions will be applied beyond standard clinical care.
Detailed description
This single-center prospective observational study enrolls adult patients undergoing elective first-time isolated coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB).
Mechanical power (MP) will be calculated as: MP = 0.098 × RR
× VT × [PIP - 0.5 × (Pplat - PEEP)], normalized to predicted body weight (norMP = MP/PBW). Male PBW (kg) = 50 + 0.91 × [height (cm) - 152.4]; female PBW (kg) = 45.5 + 0.91 × [height (cm) - 152.4]. Driving pressure (DP) = Pplat - PEEP.
Ventilatory parameters (VT, RR, peak pressure, plateau pressure, PEEP, FiO2, EtCO2) and arterial blood gases (PaO2/FiO2, PaCO2, lactate) will be recorded at four standardized time points: T1 (post-intubation), T2 (post- sternotomy), T3 (pre-bypass), and T4 (post-bypass). No additional interventions beyond standard clinical care will be applied.
Postoperative outcomes including atelectasis, pneumonia, pleural effusion, prolonged oxygen requirement, need for non-invasive ventilation, re-intubation, duration of mechanical ventilation, and ICU length of stay will be assessed within the first 48 hours.
Sample size: 110 patients (α=0.05, power=80%, expected PPC incidence 35% vs 65% in low vs high MP groups, 20% dropout allowance). Statistical analysis will include Mann-Whitney U or t-test, chi-square or Fisher exact test, and logistic regression. Significance: p<0.05 (two-tailed).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CABG Patients | – | Other: Intraoperative Mechanical Ventilation MonitoringAdult patients undergoing elective isolated CABG surgery with cardiopulmonary bypass. Intraoperative ventilatory parameters will be recorded to calculate mechanical power and driving pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective isolated CABG surgery with cardiopulmonary bypass at a single tertiary cardiac surgery center
Key inclusion criteria (5 listed)
- Age 18 years or older
- Scheduled for elective, first-time isolated CABG surgery
- Use of cardiopulmonary bypass (CPB)
- Intraoperative mechanical ventilation applied under general anesthesia with recordable ventilator data
- Provision of written informed consent
Key exclusion criteria (6 listed)
- Emergency cardiac surgery
- Off-pump CABG (without CPB)
- Preoperative requirement for invasive mechanical ventilation
- Advanced chronic lung disease
- Incomplete or unreliable intraoperative ventilatory data
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 |
|---|---|---|
| Intraoperative Mechanical Ventilation MonitoringIntraoperative ventilatory parameters (tidal volume, respiratory rate, plateau pressure, PEEP) are routinely recorded during CABG surgery. Mechanical power and driving pressure are calculated from these parameters. No additional intervention is applied beyond standard clinical care. | Other | CABG Patients |
Primary outcome
Postoperative Pulmonary Complication
Time frame: Within the first 48 hours postoperatively
Occurrence of at least one of the following within the first 48 hours postoperatively: atelectasis, pleural effusion, pneumonia, prolonged oxygen requirement, need for non-invasive ventilation (NIV), or re-intubation
1 secondary outcome
Prolonged Mechanical Ventilation
Time frame: Up to 7 days postoperatively
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 10 Jun 2026.
- Results publication: PubMed 38011027Elefterion B, Cirenei C, Kipnis E, Cailliau E, Bruandet A, Tavernier B, Lamer A, Lebuffe G. Intraoperative Mechanical Power and Postoperative Pulmonary Complications in Noncardiothoracic Elective Surgery Patients: A 10-Year Retrospective Cohort Study. Anesthesiology. 2024 Mar 1;140(3):399-408. doi: 10.1097/ALN.0000000000004848.
- Results publication: PubMed 35480074Schuijt MTU, Hol L, Nijbroek SG, Ahuja S, van Meenen D, Mazzinari G, Hemmes S, Bluth T, Ball L, Gama-de Abreu M, Pelosi P, Schultz MJ, Serpa Neto A. Associations of dynamic driving pressure and mechanical power with postoperative pulmonary complications-posthoc analysis of two randomised clinical trials in open abdominal surgery. EClinicalMedicine. 2022 Apr 16;47:101397. doi: 10.1016/j.eclinm.2022.101397. eCollection 2022 May.
- Results publication: PubMed 34597688Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.
- Results publication: PubMed 34753416Zhu Y, Peng W, Zhen S, Jiang X. Mechanical power normalized to predicted body weight is associated with mortality in critically ill patients: a cohort study. BMC Anesthesiol. 2021 Nov 10;21(1):278. doi: 10.1186/s12871-021-01497-1.
- Results publication: PubMed 41303250Li T, Zhailauova A, Wachruschew I, Kuanyshbek A, Tulegenov S, Bukirova P, Zhakupbekov B, Nikitin I, Ayaganov D, Kapyshev T, Samalavicius R, Melnikov AL, Aslanidis T. Impact of Ventilation Discontinuation During Cardiopulmonary Bypass: A Prospective Observational Study. J Clin Med. 2025 Nov 19;14(22):8215. doi: 10.3390/jcm14228215.
- Results publication: PubMed 28828361Tonetti T, Vasques F, Rapetti F, Maiolo G, Collino F, Romitti F, Camporota L, Cressoni M, Cadringher P, Quintel M, Gattinoni L. Driving pressure and mechanical power: new targets for VILI prevention. Ann Transl Med. 2017 Jul;5(14):286. doi: 10.21037/atm.2017.07.08.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. This is a single-center observational study conducted at a public hospital. Data sharing is not planned due to institutional privacy regulations and the absence of external funding requiring data sharing.
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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 Postoperative Pulmonary Complications and Coronary Artery Bypass Graft Surgery (CABG), run by Fusun Gozen 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Jun 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 Füsun Gözen, MD (Anesthesiology) (+902242955000, fusungozen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pulmonary Complication (time frame: Within the first 48 hours postoperatively). 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 NCT07639489, which also lists 6 linked publications.
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 10 Jun 2026.