Coronary Artery DiseaseFCV-PCV-DTI-LUNCT07800741
Flow-Controlled vs. Pressure-Controlled Ventilation in CABG: Effects on Lung Aeration and Diaphragm Function
A study of Coronary Artery Disease and Postoperative Pulmonary Complications, run by Koşuyolu Kartal Heart Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pulmonary atelectasis and loss of lung aeration are common complications following cardiac surgery with cardiopulmonary bypass (CPB) and are associated with impaired oxygenation and prolonged mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Postoperative Pulmonary Complications, Pulmonary Atelectasis, Postoperative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2026to 30 Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years
- Planned elective isolated on-pump coronary artery bypass graft (CABG) surgery
- ASA Physical Status Classification II-IV
- Written informed consent obtained
- Technically adequate acoustic window for lung and diaphragm ultrasonography
Who cannot join
- Emergency surgery
- Combined surgical procedures (e.g., valve repair/replacement + CABG)
- Preoperative requirement for invasive or non-invasive mechanical ventilation
- Known diaphragm paralysis or neuromuscular disease
- Severe COPD exacerbation or active pneumonia at time of surgery
- Body mass index ≥40 kg/m²
- Inability to obtain standard lung or diaphragm ultrasound images due to pleural effusion, thoracic deformity, or prior thoracic surgery
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
Kosuyolu Heart Training and Research Hospital
Istanbul, Kartal, 34862
About this study
Official title: Comparison of Flow-Controlled Ventilation and Pressure-Controlled Ventilation on Lung Aeration and Diaphragm Function in Patients Undergoing Elective Isolated On-Pump Coronary Artery Bypass Graft Surgery: A Single-Centre Prospective Randomised Controlled Trial
Pulmonary atelectasis and loss of lung aeration are common complications following cardiac surgery with cardiopulmonary bypass (CPB) and are associated with impaired oxygenation and prolonged mechanical ventilation. Diaphragm dysfunction occurring in the perioperative period may further delay extubation and prolong intensive care unit (ICU) stay. Flow-Controlled Ventilation (FCV) is a novel ventilation modality that provides continuous, flow-based delivery of tidal breaths with a triangular flow profile, potentially offering superior dynamic compliance optimisation compared to conventional Pressure-Controlled Ventilation (PCV).
Read the detailed description
This single-centre, prospective, 1:1 randomised parallel-group controlled trial will compare intraoperative FCV with PCV in adults undergoing elective isolated on-pump coronary artery bypass graft (CABG) surgery. The primary outcome is total lung ultrasound (LUS) score change (0-36 scale) from baseline (T0) to 24 hours postoperatively (T2). Secondary outcomes include diaphragm thickening fraction (TFdi), diaphragm excursion, PaO₂/FiO₂ ratio, extubation time, and ICU/hospital length of stay. Lung and diaphragm ultrasonography will be performed by an assessor blinded to group allocation at three time points: preoperatively (T0), at end of surgery while intubated (T1), and at 24 hours postoperatively after extubation (T2).
- Conditions
- Coronary Artery Disease, Postoperative Pulmonary Complications, Pulmonary Atelectasis, Postoperative, Diaphragm Dysfunction, Respiratory Insufficiency
- Being tested
- Flow-Controlled Ventilation, Pressure-Controlled Ventilation (PCV)
- Keywords
- Flow-Controlled Ventilation, Pressure-Controlled Ventilation, Lung Ultrasound, Diaphragm Ultrasonography, Diaphragm Excursion, Diaphragm Thickening Fraction, Lung-Protective Ventilation, Point-of-Care Ultrasound, Perioperative Pulmonary Complications, Cardiopulmonary Bypass, Cardiac Surgery
- Medical subject headings
- Coronary Artery Disease, Pulmonary Atelectasis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow-Controlled VentilationProcedure or surgery
FCV delivers tidal ventilation via a continuous triangular flow waveform, maintaining constant inspiratory and expiratory flow rates throughout the entire respiratory cycle. PEEP and peak airway pressure are titrated independently, guided by dynamic respiratory system compliance. Tidal volume target is 6-8 mL/kg ideal body weight. This ventilation modality is distinct from pressure-controlled and volume-controlled modes, which generate decelerating inspiratory flow profiles and do not allow simultaneous independent titration of PEEP and peak airway pressure based on compliance.
Pressure-Controlled Ventilation (PCV)Procedure or surgery
PCV is delivered using a standard anaesthesia workstation in pressure-controlled mode. Inspiratory pressure is set to achieve a tidal volume of 6-8 mL/kg ideal body weight. PEEP is titrated using the same compliance-guided algorithm applied in the FCV arm. Unlike FCV, the inspiratory flow profile is decelerating and PEEP and peak airway pressure are not independently optimised in a compliance-guided manner within the same ventilation mode
| Study group | Role | What they receive |
|---|---|---|
| FCV (Flow-Controlled Ventilation) | Experimental | Intraoperative ventilation with a Flow-Controlled Ventilation device. Target tidal volume: 6-8 mL/kg ideal body weight (IBW). PEEP and peak airway pressure titrated to maximise dynamic compliance. Respiratory rate adjusted to maintain EtCO₂ 35-45 mmHg. FiO₂ targeted to SpO₂ ≥94%. Receives: Procedure: Pressure-Controlled Ventilation (PCV) |
| PCV (Pressure-Controlled Ventilation) | Active comparator | Intraoperative pressure-controlled ventilation. Inspiratory pressure adjusted to deliver a tidal volume of 6-8 mL/kg IBW. PEEP titrated to maximise dynamic compliance, using the same algorithm as the FCV group. Respiratory rate adjusted to maintain EtCO₂ 35-45 mmHg. FiO₂ targeted to SpO₂ ≥94%. Receives: Procedure: Flow-Controlled Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Lung Ultrasound Score (LUS)
Lung aeration assessed using a 12-zone bilateral ultrasonography protocol. Each zone scored 0-3 (0 = normal aeration with A-lines; 1 = multiple B-lines; 2 = coalescent B-lines; 3 = consolidation). Total score ranges from 0 to 36; higher scores indicate greater aeration loss
Measured: Preoperatively (T0), within 30 minutes of sternal closure while intubated (T1), and 24 hours postoperatively after extubation (T2)
Secondary outcomes (4)
Diaphragm Thickening Fraction (TFdi)
Bilateral diaphragm thickening fraction measured via B-mode and M-mode ultrasonography at the zone of apposition using a linear probe (7-12 MHz). TFdi (%) = [(T_insp - T_exp) / T_exp] × 100.
Measured: Preoperatively (T0), within 30 minutes of sternal closure while intubated (T1), and 24 hours postoperatively after extubation (T2)
Diaphragm Excursion
Bilateral inspiratory diaphragm dome displacement measured via M-mode ultrasonography using a convex probe (2-5 MHz) via subcostal approach.
Measured: Preoperatively (T0), within 30 minutes of sternal closure while intubated (T1), and 24 hours postoperatively after extubation (T2)
PaO₂/FiO₂ Ratio
Ratio of arterial oxygen partial pressure to fractional inspired oxygen, calculated from arterial blood gas analysis.
Measured: Preoperatively (T0), within 30 minutes of sternal closure while intubated (T1), and 24 hours postoperatively after extubation (T2)
Postoperative Pulmonary Complications
Composite of clinically significant pulmonary complications including radiologically confirmed atelectasis, pneumonia, and re-intubation, assessed according to pre-specified definitions.
Measured: Up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
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
- Model description
- This is a single-centre, prospective, randomised, parallel-group controlled trial comparing two intraoperative ventilation strategies - Flow-Controlled Ventilation (FCV) and Pressure-Controlled Ventilation (PCV) - in adults undergoing elective isolated on-pump coronary artery bypass graft (CABG) surgery. A parallel-group design was selected because the two ventilation modes are mutually exclusive within a single surgical procedure; crossover is not feasible.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koşuyolu Kartal Heart Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Girgin Dinc, Koşuyolu Kartal Heart Training and Research Hospital
- Investigators
- Ebru GIRGIN DINC, Principal investigator, Koşuyolu Kartal Heart Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800741
- Sponsor's protocol ID
- FCV-PCV-DTI-LUS
- Acronym
- FCV-PCV-DTI-LU
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Flow-Controlled Ventilation and Pressure-Controlled Ventilation on Lung Aeration and Diaphragm Function in Patients Undergoing Elective Isolated On-Pump Coronary Artery Bypass Graft Surgery: A Single-Centre Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07800741
- Acronym / sponsor ID
- FCV-PCV-DTI-LU / FCV-PCV-DTI-LUS
- Conditions
- Coronary Artery Disease, Postoperative Pulmonary Complications, Pulmonary Atelectasis, Postoperative, Diaphragm Dysfunction, Respiratory Insufficiency
- Keywords
- Flow-Controlled Ventilation, Pressure-Controlled Ventilation, Lung Ultrasound, Diaphragm Ultrasonography, Diaphragm Excursion, Diaphragm Thickening Fraction, Lung-Protective Ventilation, Point-of-Care Ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Koşuyolu Kartal Heart Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 2 Sep 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.
Pulmonary atelectasis and loss of lung aeration are common complications following cardiac surgery with cardiopulmonary bypass (CPB) and are associated with impaired oxygenation and prolonged mechanical ventilation. Diaphragm dysfunction occurring in the perioperative period may further delay extubation and prolong intensive care unit (ICU) stay. Flow-Controlled Ventilation (FCV) is a novel ventilation modality that provides continuous, flow-based delivery of tidal breaths with a triangular flow profile, potentially offering superior dynamic compliance optimisation compared to conventional Pressure-Controlled Ventilation (PCV).
Detailed description
This single-centre, prospective, 1:1 randomised parallel-group controlled trial will compare intraoperative FCV with PCV in adults undergoing elective isolated on-pump coronary artery bypass graft (CABG) surgery. The primary outcome is total lung ultrasound (LUS) score change (0-36 scale) from baseline (T0) to 24 hours postoperatively (T2). Secondary outcomes include diaphragm thickening fraction (TFdi), diaphragm excursion, PaO₂/FiO₂ ratio, extubation time, and ICU/hospital length of stay. Lung and diaphragm ultrasonography will be performed by an assessor blinded to group allocation at three time points: preoperatively (T0), at end of surgery while intubated (T1), and at 24 hours postoperatively after extubation (T2).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-centre, prospective, randomised, parallel-group controlled trial comparing two intraoperative ventilation strategies - Flow-Controlled Ventilation (FCV) and Pressure-Controlled Ventilation (PCV) - in adults undergoing elective isolated on-pump coronary artery bypass graft (CABG) surgery. A parallel-group design was selected because the two ventilation modes are mutually exclusive within a single surgical procedure; crossover is not feasible.
| Arm | Type | Receives |
|---|---|---|
| FCV (Flow-Controlled Ventilation) | Experimental | Procedure: Pressure-Controlled Ventilation (PCV)Intraoperative ventilation with a Flow-Controlled Ventilation device. Target tidal volume: 6-8 mL/kg ideal body weight (IBW). PEEP and peak airway pressure titrated to maximise dynamic compliance. Respiratory rate adjusted to maintain EtCO₂ 35-45 mmHg. FiO₂ targeted to SpO₂ ≥94%. |
| PCV (Pressure-Controlled Ventilation) | Active comparator | Procedure: Flow-Controlled VentilationIntraoperative pressure-controlled ventilation. Inspiratory pressure adjusted to deliver a tidal volume of 6-8 mL/kg IBW. PEEP titrated to maximise dynamic compliance, using the same algorithm as the FCV group. Respiratory rate adjusted to maintain EtCO₂ 35-45 mmHg. FiO₂ targeted to SpO₂ ≥94%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Planned elective isolated on-pump coronary artery bypass graft (CABG) surgery
- ASA Physical Status Classification II-IV
- Written informed consent obtained
- Technically adequate acoustic window for lung and diaphragm ultrasonography
Key exclusion criteria (7 listed)
- Emergency surgery
- Combined surgical procedures (e.g., valve repair/replacement + CABG)
- Preoperative requirement for invasive or non-invasive mechanical ventilation
- Known diaphragm paralysis or neuromuscular disease
- Severe COPD exacerbation or active pneumonia at time of 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 |
|---|---|---|
| Flow-Controlled VentilationFCV delivers tidal ventilation via a continuous triangular flow waveform, maintaining constant inspiratory and expiratory flow rates throughout the entire respiratory cycle. PEEP and peak airway pressure are titrated independently, guided by dynamic respiratory system compliance. Tidal volume target is 6-8 mL/kg ideal body weight. This ventilation modality is distinct from pressure-controlled and volume-controlled modes, which generate decelerating inspiratory flow profiles and do not allow simultaneous independent titration of PEEP and peak airway pressure based on compliance. | Procedure or surgery | PCV (Pressure-Controlled Ventilation) |
| Pressure-Controlled Ventilation (PCV)PCV is delivered using a standard anaesthesia workstation in pressure-controlled mode. Inspiratory pressure is set to achieve a tidal volume of 6-8 mL/kg ideal body weight. PEEP is titrated using the same compliance-guided algorithm applied in the FCV arm. Unlike FCV, the inspiratory flow profile is decelerating and PEEP and peak airway pressure are not independently optimised in a compliance-guided manner within the same ventilation mode | Procedure or surgery | FCV (Flow-Controlled Ventilation) |
Primary outcome
Total Lung Ultrasound Score (LUS)
Time frame: Preoperatively (T0), within 30 minutes of sternal closure while intubated (T1), and 24 hours postoperatively after extubation (T2)
Lung aeration assessed using a 12-zone bilateral ultrasonography protocol. Each zone scored 0-3 (0 = normal aeration with A-lines; 1 = multiple B-lines; 2 = coalescent B-lines; 3 = consolidation). Total score ranges from 0 to 36; higher scores indicate greater aeration loss
4 secondary outcomes
Diaphragm Thickening Fraction (TFdi)
Time frame: Preoperatively (T0), within 30 minutes of sternal closure while intubated (T1), and 24 hours postoperatively after extubation (T2)
Diaphragm Excursion
Time frame: Preoperatively (T0), within 30 minutes of sternal closure while intubated (T1), and 24 hours postoperatively after extubation (T2)
PaO₂/FiO₂ Ratio
Time frame: Preoperatively (T0), within 30 minutes of sternal closure while intubated (T1), and 24 hours postoperatively after extubation (T2)
Postoperative Pulmonary Complications
Time frame: Up to 30 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 2 Sep 2026.
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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.
Ebru GIRGIN DINC principal investigator
Koşuyolu Kartal Heart Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Coronary Artery Disease and Postoperative Pulmonary Complications, run by Koşuyolu Kartal Heart Training and Research 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 5 inclusion and 7 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 2 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 Ebru GIRGIN DINC, M.D., DESAIC (905446948852, grgnebru@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Lung Ultrasound Score (LUS) (time frame: Preoperatively (T0), within 30 minutes of sternal closure while intubated (T1), and 24 hours postoperatively after extubation (T2)). 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 Sep 2026.