Coronary Artery DiseaseNCT07073885
Effect of Ultra-Low Tidal Volume on Mechanical Power During Heart Bypass Surgery
A study testing Ultra-Low Tidal Volume Ventilation and Apnea Group in people with Coronary Artery Disease, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate whether ultra-low tidal volume (ULTV) ventilation during cardiopulmonary bypass (CPB) can reduce mechanical power (MP) and improve postoperative respiratory outcomes in adult patients undergoing elective coronary artery bypass graft (CABG) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ultra-Low Tidal Volume Ventilation and Apnea Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2025to 20 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex aged over 18 years
- Patients classified as ASA II-IV
- Patients scheduled for elective CABG
Who cannot join
- Presence of severe COPD
- Uncontrolled bronchial asthma
- Decompensated heart failure (NYHA class III-IV)
- Pulmonary hypertension
- History of lung surgery
- Morbid obesity (BMI >35)
- Emergency surgery cases
- Patients who decline to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ultra-Low Tidal Volume Ventilation on Mechanical Power in Coronary Artery Bypass Graft Surgery
The goal of this clinical trial is to evaluate whether ultra-low tidal volume (ULTV) ventilation during cardiopulmonary bypass (CPB) can reduce mechanical power (MP) and improve postoperative respiratory outcomes in adult patients undergoing elective coronary artery bypass graft (CABG) surgery.
The main questions it aims to answer are:
Read more
Does ULTV ventilation during CPB result in lower intraoperative mechanical power compared to apnea?
Can ULTV ventilation reduce extubation time and ICU (Intensive Care Unit) stay and improve the PaO₂/FiO₂ ratio (Partial Pressure of Arterial Oxygen / Fraction of Inspired Oxygen Ratio)?
Researchers will compare patients receiving ULTV ventilation to those undergoing apnea after aortic cross-clamping to assess the effects on mechanical power and postoperative outcomes.
Participants will:
Be randomized to either ULTV ventilation or apnea group
Undergo standard general anesthesia and CABG surgery
Have mechanical power measured at three time points (pre-CPB, post-CPB, and ICU pre-extubation)
Have arterial blood gases evaluated for PaO₂/FiO₂ ratios
Be monitored for extubation time and ICU length of stay
This study aims to generate evidence that could inform safer and more protective intraoperative ventilation strategies during cardiac surgery.
Read the detailed description
This is a prospective, randomized, assessor-blinded, single-center clinical trial designed to evaluate the effects of ultra-low tidal volume (ULTV) ventilation on intraoperative mechanical power (MP) and postoperative pulmonary outcomes in patients undergoing elective coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB).
After obtaining informed consent, eligible adult patients (ASA II-IV) scheduled for elective CABG will be randomly assigned to one of two groups:
ULTV Group: Ventilation will be continued after aortic cross-clamping using volume-controlled ventilation with a tidal volume of 3-4 mL/kg ideal body weight, 12-15 breaths per minute, 5 cm H₂O PEEP, and 50% FiO₂.
Apnea Group: Mechanical ventilation will be discontinued after aortic cross-clamping, and patients will remain apneic during CPB.
Mechanical power will be calculated using a validated surrogate formula and measured at three key time points: pre-CPB (baseline), post-CPB (before ICU transfer), and at the 2nd postoperative hour in the ICU (before extubation). Arterial blood gases will be obtained to determine PaO₂/FiO₂ ratios at these time points and 24 hours post-extubation.
Secondary outcomes include extubation time and length of ICU stay.
This study aims to generate evidence supporting the potential protective effects of continued low-volume ventilation during CPB, with a focus on reducing ventilator-induced lung injury by limiting mechanical power and preserving alveolar integrity.
- Conditions
- Coronary Artery Disease
- Being tested
- Ultra-Low Tidal Volume Ventilation, Apnea Group
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-Low Tidal Volume VentilationOther
Ventilation continued during CPB using volume-controlled mode with ultra-low tidal volume (3-4 mL/kg IBW(Ideal Body Weight)), 12-15 breaths/min, 5 cm H₂O PEEP, and 50% FiO₂.
Apnea GroupOther
In this group, mechanical ventilation will be discontinued after aortic cross-clamping during CPB, and apnea will be maintained throughout the bypass period.
| Study group | Role | What they receive |
|---|---|---|
| Group ULTV | Experimental | Participants in this group will continue to receive mechanical ventilation after aortic cross-clamping during cardiopulmonary bypass (CPB). Ventilation will be provided in volume-controlled mode with a tidal volume of 3-4 mL/kg ideal body weight, respiratory rate of 12-15 breaths/min, 5 cm H₂O PEEP (Positive End-Expiratory Pressure), and 50% FiO₂.
. Receives: Other: Ultra-Low Tidal Volume Ventilation |
| Apnea Group | Active comparator | After the application of the aortic cross-clamp, mechanical ventilation will be discontinued, and apnea will be maintained. Receives: Other: Apnea Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Power
Primary Aim Measurements Calculation of Mechanical Power (MP)
Several methods exist for measuring MP. In this study, a simplified and validated method will be employed. The formula is expressed as follows:
MP (J/min) = 0.098 × RR × Vt × (PEEP + ½[Pplat - PEEP] + [Ppeak - Pplat]) (RR: Respiratory Rate, Vt : Tidal Volume, PEEP: Positive End-Expiratory Pressure, Pplat: Plateau Pressure, Ppeak: Peak Inspiratory Pressure).
Thus, MP is calculated as the product of the work per individual breath (volume × pressure) multiplied by the respiratory rate. Primary evaluation parameters will be computed using ventilator settings, with three consecutive measurements taken and averaged for accuracy.
Measured: MP Measurements (Mechanical Power)MP 1: Baseline (after intubation and before surgical incision)MP 2: At the end of surgery (prior to ICU admission)MP 3: Postoperative 2nd hour in ICU (prior to extubation)
Secondary outcomes (3)
extubation time
Extubation time is defined as the duration (in hours) from the end of surgery to the time of tracheal extubation.
Measured: From the end of surgery until the time of tracheal extubation, assessed up to 24 hours postoperatively.
duration of intensive care unit (ICU) stay.
Defined as the number of calendar days the patient remains in the intensive care unit (ICU) following surgery, until transfer to the general ward. Data will be collected daily during ICU stay.
Measured: From ICU admission following surgery until ICU discharge, assessed up to 7 days postoperatively.
PaO₂/FiO₂ ratio.
PaO₂/FiO₂ ratios will be calculated from arterial blood gas samples obtained at four predefined time points: after intubation and before surgical incision (preoperative baseline), at the end of surgery (prior to ICU admission), at the 2nd postoperative hour in the ICU (before extubation), and at the 24th hour following extubation.
Measured: 1. Baseline (after intubation, before surgical incision)2. At the end of surgery (prior to ICU admission)3. Postoperative 2nd hour in ICU (prior to extubation)4. 24 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start10 Oct 2025
- Primary completion15 Feb 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esma Karaarslan, Konya City Hospital
- Investigators
- Esma karaarslan, MD, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073885
- Sponsor's protocol ID
- CABGO-MP
- Status last verified
- Feb 2026
- First submitted
- 2 Jul 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: maybe, we can share all info after finish the study
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultra-Low Tidal Volume Ventilation on Mechanical Power in Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT07073885
- Acronym / sponsor ID
- CABGO-MP
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 18 Jul 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.
The goal of this clinical trial is to evaluate whether ultra-low tidal volume (ULTV) ventilation during cardiopulmonary bypass (CPB) can reduce mechanical power (MP) and improve postoperative respiratory outcomes in adult patients undergoing elective coronary artery bypass graft (CABG) surgery.
The main questions it aims to answer are:
Does ULTV ventilation during CPB result in lower intraoperative mechanical power compared to apnea?
Can ULTV ventilation reduce extubation time and ICU (Intensive Care Unit) stay and improve the PaO₂/FiO₂ ratio (Partial Pressure of Arterial Oxygen / Fraction of Inspired Oxygen Ratio)?
Researchers will compare patients receiving ULTV ventilation to those undergoing apnea after aortic cross-clamping to assess the effects on mechanical power and postoperative outcomes.
Participants will:
Be randomized to either ULTV ventilation or apnea group
Undergo standard general anesthesia and CABG surgery
Have mechanical power measured at three time points (pre-CPB, post-CPB, and ICU pre-extubation)
Have arterial blood gases evaluated for PaO₂/FiO₂ ratios
Be monitored for extubation time and ICU length of stay
This study aims to generate evidence that could inform safer and more protective intraoperative ventilation strategies during cardiac surgery.
Detailed description
This is a prospective, randomized, assessor-blinded, single-center clinical trial designed to evaluate the effects of ultra-low tidal volume (ULTV) ventilation on intraoperative mechanical power (MP) and postoperative pulmonary outcomes in patients undergoing elective coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB).
After obtaining informed consent, eligible adult patients (ASA II-IV) scheduled for elective CABG will be randomly assigned to one of two groups:
ULTV Group: Ventilation will be continued after aortic cross-clamping using volume-controlled ventilation with a tidal volume of 3-4 mL/kg ideal body weight, 12-15 breaths per minute, 5 cm H₂O PEEP, and 50% FiO₂.
Apnea Group: Mechanical ventilation will be discontinued after aortic cross-clamping, and patients will remain apneic during CPB.
Mechanical power will be calculated using a validated surrogate formula and measured at three key time points: pre-CPB (baseline), post-CPB (before ICU transfer), and at the 2nd postoperative hour in the ICU (before extubation). Arterial blood gases will be obtained to determine PaO₂/FiO₂ ratios at these time points and 24 hours post-extubation.
Secondary outcomes include extubation time and length of ICU stay.
This study aims to generate evidence supporting the potential protective effects of continued low-volume ventilation during CPB, with a focus on reducing ventilator-induced lung injury by limiting mechanical power and preserving alveolar integrity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ULTV | Experimental | Other: Ultra-Low Tidal Volume VentilationParticipants in this group will continue to receive mechanical ventilation after aortic cross-clamping during cardiopulmonary bypass (CPB). Ventilation will be provided in volume-controlled mode with a tidal volume of 3-4 mL/kg ideal body weight, respiratory rate of 12-15 breaths/min, 5 cm H₂O PEEP (Positive End-Expiratory Pressure), and 50% FiO₂. . |
| Apnea Group | Active comparator | Other: Apnea GroupAfter the application of the aortic cross-clamp, mechanical ventilation will be discontinued, and apnea will be maintained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of either sex aged over 18 years
- Patients classified as ASA II-IV
- Patients scheduled for elective CABG
Key exclusion criteria (8 listed)
- Presence of severe COPD
- Uncontrolled bronchial asthma
- Decompensated heart failure (NYHA class III-IV)
- Pulmonary hypertension
- History of lung surgery
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 |
|---|---|---|
| Ultra-Low Tidal Volume VentilationVentilation continued during CPB using volume-controlled mode with ultra-low tidal volume (3-4 mL/kg IBW(Ideal Body Weight)), 12-15 breaths/min, 5 cm H₂O PEEP, and 50% FiO₂. | Other | Group ULTV |
| Apnea GroupIn this group, mechanical ventilation will be discontinued after aortic cross-clamping during CPB, and apnea will be maintained throughout the bypass period. | Other | Apnea Group |
Primary outcome
Mechanical Power
Time frame: MP Measurements (Mechanical Power)MP 1: Baseline (after intubation and before surgical incision)MP 2: At the end of surgery (prior to ICU admission)MP 3: Postoperative 2nd hour in ICU (prior to extubation)
Primary Aim Measurements Calculation of Mechanical Power (MP) Several methods exist for measuring MP. In this study, a simplified and validated method will be employed. The formula is expressed as follows: MP (J/min) = 0.098 × RR × Vt × (PEEP + ½[Pplat - PEEP] + [Ppeak - Pplat]) (RR: Respiratory Rate, Vt : Tidal Volume, PEEP: Positive End-Expiratory Pressure, Pplat: Plateau Pressure, Ppeak: Peak Inspiratory Pressure). Thus, MP is calculated as the product of the work per individual breath (volume × pressure) multiplied by the respiratory rate. Primary evaluation parameters will be computed using ventilator settings, with three consecutive measurements taken and averaged for accuracy.
3 secondary outcomes
extubation time
Time frame: From the end of surgery until the time of tracheal extubation, assessed up to 24 hours postoperatively.
duration of intensive care unit (ICU) stay.
Time frame: From ICU admission following surgery until ICU discharge, assessed up to 7 days postoperatively.
PaO₂/FiO₂ ratio.
Time frame: 1. Baseline (after intubation, before surgical incision)2. At the end of surgery (prior to ICU admission)3. Postoperative 2nd hour in ICU (prior to extubation)4. 24 hours after extubation
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 2 Mar 2026.
- Individual participant dataSharing planned: Yes. maybe, we can share all info after finish the study
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Esma karaarslan, MD principal investigator
Konya 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 Ultra-Low Tidal Volume Ventilation and Apnea Group in people with Coronary Artery Disease, run by Konya City Hospital 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 8 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 2 Mar 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?
Mechanical Power (time frame: MP Measurements (Mechanical Power)MP 1: Baseline (after intubation and before surgical incision)MP 2: At the end of surgery (prior to ICU admission)MP 3: Postoperative 2nd hour in ICU (prior to extubation)). 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 2 Mar 2026.