Flow-Controlled vs. Pressure-Controlled Ventilation in CABG: Effects on Lung Aeration and Diaphragm Function

Sponsor
Koşuyolu Kartal Heart Training and Research Hospital
Study ID
NCT07800741
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease
  • Diaphragm Dysfunction
  • Postoperative Pulmonary Complications
  • Pulmonary Atelectasis, Postoperative
  • Respiratory Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Flow-Controlled Ventilation — PROCEDURE
    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
    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 Details

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).

Key Dates

First listed
Sep 2, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
154 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: FCV (Flow-Controlled Ventilation)
    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%.
  • Active Comparator: PCV (Pressure-Controlled Ventilation)
    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%.

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) ]

Central Contacts

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