Postoperative Pulmonary AtelectasisNCT06292767
Cardiopulmonary Bypass on Mechanical Power and Postoperative Pulmonary Complications
An observational study of Postoperative Pulmonary Atelectasis and Pneumothorax, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
During cardiopulmonary bypass (CPB), oxygenation of the patient on the pump can be left completely under pump control, or the lungs can be ventilated with low tidal volume to reduce atelectasis. In recent years, the concept of mechanical power has been used to determine the extent of ventilator-related lung damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Atelectasis, Pneumothorax, Pneumonia
- What is being tested?
- mechanical power calculation
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 25 Apr 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are over 18 years and agree to participate in the study.
Who may be able to join
None listed.
Who cannot join
- Patients undergoing emergency cardiac surgery
- Patients who will undergo redo surgery
- Patients who will undergo total circulatory arrest surgery
- Patients in a state of preoperative shock
- Patients with acute and chronic hypoxemia (PaO2 <65mmHg, SpO2 <95 in room air)
- Patients followed with mechanical ventilation for 7 days before surgery
Show all 10Show fewer
- Patients with BMI>35
- Patients with obstructive sleep apnea syndrome
- Patients with pulmonary artery pressure >50 mmHg
- Patients with glomerular filtration rate <30 ml/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Two Different Mechanical Ventilation Strategies During Cardiopulmonary Bypass on Mechanical Power and Postoperative Pulmonary Complications
During cardiopulmonary bypass (CPB), oxygenation of the patient on the pump can be left completely under pump control, or the lungs can be ventilated with low tidal volume to reduce atelectasis. In recent years, the concept of mechanical power has been used to determine the extent of ventilator-related lung damage. This concept of mechanical power, by which the energy transferred by the ventilator to the lungs can be calculated, will be measured at certain intervals in CPB surgery patients on the pump and compared between the two groups. The investigators aimed to investigate the effect of two different ventilation methods on mechanical power and its relationship with postoperative pulmonary complications.
Read the detailed description
Patients will be taken to the operating table after preoperative evaluation. Routine monitoring and routine anesthesia method will be applied to the patient. Access will be made through the radial artery for arterial catheterization. Patients will be ventilated with 6-8 ml/kg tidal volume, 12-14 frequency/min, 5 Positive end expiratory pressure(PEEP), 60% Fraction of inspired oxygen(FiO2) and oxygen saturation over 94. End tidal Carbon dixide(CO2) will be kept in the range of 32-37. After cardiac catheterizations are performed, the pump will be entered, and after all preparations are completed, an aortic cross-clamp will be placed and cardioplegic solution will be sent. After the patient enters the pump at full flow; Group 1: Non-ventilated patient group. Here, patients will be placed in the cardiac bypass mode of the anesthesia machine. Only 150 ml of free air flow will be provided and mechanical ventilation will be turned off.
Group 2: Patients will continue to be ventilated at FiO2: 40%, TV: 3 ml/kg, frequency 12 breaths/min, peep: 5 cm/H2O.
- Being tested
- mechanical power calculation
- Medical subject headings
- Pulmonary Atelectasis, Pneumothorax, Pneumonia, Acute Lung Injury, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical power calculationOther
Mechanical Power= 0.098×Minute ventilation× (peak pressure - 0.5 (plato pressure-PEEP)). These parameters are monitored on the monitor while the patient is mechanically ventilated and placed into the equation
| Study group | Role | What they receive |
|---|---|---|
| Not ventilated | Non-ventilated patient group.Patients will be placed in the cardiac bypass mode of the anesthesia machine. Only 150 ml of free air flow will be provided and mechanical ventilation will be turned off. Receives: Other: mechanical power calculation | |
| Ventilated | Patients will continue to be ventilated at Fraction of inspired oxygen(FiO2): 40%, Tidal volume(TV): 3 ml/kg, frequency 12 breaths/min, Positive end expiratory pressure (Peep): 5 cm/H2O. Receives: Other: mechanical power calculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mechanical power
mechanical power=0.098*minute ventilation *(Ppeak-0.5*(Pplato-PEEP)
Measured: intraoperative
Secondary outcomes (1)
mechanical power
mechanical power=0.098*minute ventilation *(Ppeak-0.5*(Pplato-PEEP)
Measured: postoperative in intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start15 Mar 2024
- Primary completion15 Jan 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary AtelectasisStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Talih, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292767
- Sponsor's protocol ID
- 2023/462
- Status last verified
- Jun 2025
- First submitted
- 24 Jan 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Two Different Mechanical Ventilation Strategies During Cardiopulmonary Bypass on Mechanical Power and Postoperative Pulmonary Complications
- ClinicalTrials.gov ID
- NCT06292767
- Acronym / sponsor ID
- 2023/462
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 5 Mar 2024 (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.
During cardiopulmonary bypass (CPB), oxygenation of the patient on the pump can be left completely under pump control, or the lungs can be ventilated with low tidal volume to reduce atelectasis. In recent years, the concept of mechanical power has been used to determine the extent of ventilator-related lung damage. This concept of mechanical power, by which the energy transferred by the ventilator to the lungs can be calculated, will be measured at certain intervals in CPB surgery patients on the pump and compared between the two groups. The investigators aimed to investigate the effect of two different ventilation methods on mechanical power and its relationship with postoperative pulmonary complications.
Detailed description
Patients will be taken to the operating table after preoperative evaluation. Routine monitoring and routine anesthesia method will be applied to the patient. Access will be made through the radial artery for arterial catheterization. Patients will be ventilated with 6-8 ml/kg tidal volume, 12-14 frequency/min, 5 Positive end expiratory pressure(PEEP), 60% Fraction of inspired oxygen(FiO2) and oxygen saturation over 94. End tidal Carbon dixide(CO2) will be kept in the range of 32-37. After cardiac catheterizations are performed, the pump will be entered, and after all preparations are completed, an aortic cross-clamp will be placed and cardioplegic solution will be sent. After the patient enters the pump at full flow; Group 1: Non-ventilated patient group. Here, patients will be placed in the cardiac bypass mode of the anesthesia machine. Only 150 ml of free air flow will be provided and mechanical ventilation will be turned off.
Group 2: Patients will continue to be ventilated at FiO2: 40%, TV: 3 ml/kg, frequency 12 breaths/min, peep: 5 cm/H2O.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Not ventilated | – | Other: mechanical power calculationNon-ventilated patient group.Patients will be placed in the cardiac bypass mode of the anesthesia machine. Only 150 ml of free air flow will be provided and mechanical ventilation will be turned off. |
| Ventilated | – | Other: mechanical power calculationPatients will continue to be ventilated at Fraction of inspired oxygen(FiO2): 40%, Tidal volume(TV): 3 ml/kg, frequency 12 breaths/min, Positive end expiratory pressure (Peep): 5 cm/H2O. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are over 18 years and agree to participate in the study.
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Patients undergoing emergency cardiac surgery
- Patients who will undergo redo surgery
- Patients who will undergo total circulatory arrest surgery
- Patients in a state of preoperative shock
- Patients with acute and chronic hypoxemia (PaO2 <65mmHg, SpO2 <95 in room air)
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 |
|---|---|---|
| mechanical power calculationMechanical Power= 0.098×Minute ventilation× (peak pressure - 0.5 (plato pressure-PEEP)). These parameters are monitored on the monitor while the patient is mechanically ventilated and placed into the equation | Other | Not ventilated, Ventilated |
Primary outcome
mechanical power
Time frame: intraoperative
mechanical power=0.098*minute ventilation *(Ppeak-0.5*(Pplato-PEEP)
1 secondary outcome
mechanical power
Time frame: postoperative in intensive care unit
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 26 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atelectasis and Pneumothorax, run by TC Erciyes 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 0 inclusion and 10 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 26 Jun 2025. 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?
mechanical power (time frame: intraoperative). 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 26 Jun 2025.