Individualized flow-controlled versus conventional pressure-controlled ventilation in on-pump heart surgery (FLOWVENTIN HEARTSURG): study protocol for a randomized controlled trial

In on-pump cardiac surgery, lungs are at high risk of periprocedural organ impairment because of atelectasis formation, ventilator-induced lung injury, and hyperinflammation due to the cardiopulmonary bypass which results in postoperative pulmonary complications in half of this patient population. T...

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Bibliographic Details
Published in:	Current controlled trials in cardiovascular medicine 2023-03, Vol.24 (1), p.195-195, Article 195
Main Authors:	Becker, Simon, Schnitzler, Romina, Rembecki, Martin, Geppert, Johannes, Kurz, Christian T, Wichelhaus, Lisa-Marie, Timmesfeld, Nina, Zahn, Peter K
Format:	Article
Language:	eng
Subjects:	Analysis Cardiac surgery Cardiac Surgical Procedures - adverse effects Cardiac Surgical Procedures - methods Cardiopulmonary bypass Clinical medicine Clinical trials Complications Complications and side effects Consent Coronary artery bypass Corporate sponsorship Flow-controlled ventilation General anesthesia Health aspects Heart surgery Heart, Mechanical Hospitals Humans Impedance, Bioelectric Inflammation Intensive care Ischemia Lung - surgery Lungs Patients Positive-Pressure Respiration - adverse effects Positive-Pressure Respiration - methods Postoperative Complications - epidemiology Postoperative Complications - etiology Postoperative Complications - prevention & control Postoperative pulmonary complications Pressure-controlled ventilation Prevention Randomized Controlled Trials as Topic Respiration, Artificial - adverse effects Respiration, Artificial - methods Respiratory distress syndrome Risk factors Study Protocol Surgery Tidal Volume - physiology Ventilator-associated pneumonia Ventilator-Induced Lung Injury Ventilators Weaning
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Summary:	In on-pump cardiac surgery, lungs are at high risk of periprocedural organ impairment because of atelectasis formation, ventilator-induced lung injury, and hyperinflammation due to the cardiopulmonary bypass which results in postoperative pulmonary complications in half of this patient population. The new ventilation mode flow-controlled ventilation (FCV) uniquely allows full control of ins- and expiratory airway flows. This approach reduces the mechanical power of invasive ventilation as a possible cause of ventilator-induced lung injury. The scope of FLOWVENTIN HEARTSURG is to compare perioperative individualized FCV with best clinical practice pressure-controlled ventilation (PVC) modes in patients with elective on-pump cardiac surgery procedures. We hypothesize that the postoperative inflammatory response can be reduced by the perioperative application of FCV compared to PCV. FLOWVENTIN HEARTSURG is a single-center, randomized, parallel-group trial with two intervention arms: perioperative PCV modes (n = 70, PCV group) with an individualized positive end-expiratory pressure (PEEP) and a tidal volume of 6-8 ml/kg predicted bodyweight compared to perioperative FCV (n = 70, FCV group) with an individualized PEEP and driving pressure, resulting in a liberal tidal volume. As the primary study endpoint interleukin 8 plasma level is assessed 6 h after cardiopulmonary bypass as a surrogate biomarker of systemic and pulmonary inflammation. As secondary aims clinically relevant patient outcomes are analyzed, e.g., perioperative lung function regarding oxygenation indices, postoperative pulmonary and extra-pulmonary complications, SIRS-free days as well as ICU and total inpatient stays. As additional sub-studies with an exploratory approach perioperative right ventricular function parameters are assessed by echocardiography and perioperative lung aeration by electrical impedance tomography. Current paradigms regarding protective low tidal volume ventilation are consciously left in the FCV intervention group in order to reduce mechanical power as a determinant of ventilator-induced lung injury in this high-risk patient population and procedures. This approach will be compared in a randomized controlled trial with current best clinical practice PCV in FLOWVENTIN HEARTSURG. German Clinical Trials Register DRKS00018956 . Registered on 12 June 2020 (Version 1), last update on 22 August 2022 (Version 4).
ISSN:	1745-6215 1745-6215 1468-6694