An interventional study of Flow-Controlled Ventilation and Pressure-Controlled Ventilation (PCV) in Coronary Artery Disease, Postoperative Pulmonary Complications and Pulmonary Atelectasis, Postoperative, sponsored by Koşuyolu Kartal Heart Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Koşuyolu Kartal Heart Training and Research Hospital · Not applicable, Interventional, and Prevention
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).
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).
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 154 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Koşuyolu Kartal Heart Training and Research Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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%.
Procedure: Pressure-Controlled Ventilation (PCV)
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%.
Procedure: Flow-Controlled Ventilation
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.
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
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
Time frame: Preoperatively (T0), within 30 minutes of sternal closure while intubated (T1), and 24 hours postoperatively after extubation (T2)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 30 days postoperatively
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Koşuyolu Kartal Heart Training and Research Hospital