Flow Controlled Ventilation in Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT04306757|
Recruitment Status : Completed
First Posted : March 13, 2020
Last Update Posted : March 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Respiration; Artificial Positive-Pressure Respiration||Device: Evone Device: Primus||Not Applicable|
The aim of the study is to investigate flow-controlled ventilation (FCV) during cardiac surgery requiring cardiopulmonary bypass. Previous preclinical trials have already shown improved oxygenation and CO2 removal within a significantly reduced respiratory minute volume as an expression of more efficient gas exchange with FCV compared to volume controlled ventilation (VCV). Preliminary data of our own animal study comparing individualized FCV by compliance guided pressure settings with state-of-the-art low tidal volume pressure controlled ventilation (PCV) confirmed previous findings with a significantly improved oxygenation by 20% while reducing respiratory minute volume. We therefore assume that FCV may be a more lung protective ventilation method.
Open heart surgery requires bridging of the heart and lung function with a cardiopulmonary bypass (CPB) performed by a heart-lung machine. During this time the lung is most frequently not ventilated at all and lies collapsed in the chest for several hours. After weaning from CPB, the lungs must be recruited and ensure sufficient gas exchange of the blood. Not surprisingly, the incidence of postoperative pulmonary complications (PPC) at 20-30% is comparatively high after cardiac surgery and is the leading cause of perioperative mortality. Based on previous trials we expect improved oxygenation and thus arterial partial pressure of oxygen (pO2) is the main primary outcome parameter of this study. Furthermore, we expect improved recruitment of lung tissue due to controlled expiratory flow in FCV without the need of recruitment maneuvers, which may cause deleterious effects on lung tissue. Thus, lung tissue aeration assessed by Hounsfield units analyses of a postoperative computed tomography will be a secondary outcome parameter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||controlled, prospective|
|Masking:||None (Open Label)|
|Official Title:||Flow Controlled Ventilation Versus Pressure Controlled Ventilation in Cardiac Surgery After Cardiopulmonary Bypass Without Ventilation - a Prospective, Randomized Clinical Study|
|Actual Study Start Date :||March 6, 2020|
|Actual Primary Completion Date :||March 2, 2021|
|Actual Study Completion Date :||March 2, 2021|
Artificial ventilation will be performed with individualized flow-controlled ventilation (Evone, Ventinova Medical B.V., Eindhoven, the Netherlands) during cardiac surgery until admission to postoperative ICU. Individualisation will be established by compliance guided end-expiratory and peak pressure setting, flow setting will be adjusted to secure normocapnia and I:E Ratio set to 1:1.
Airway ventilation device
Active Comparator: PCV
Artificial ventilation will be performed with low tidal volume pressure-controlled ventilation (Primus, Dräger, Lübeck, Germany) during cardiac surgery until admission to postoperative ICU. Peak pressure will be set to achieve a tidal volume of 7ml/kg predicted body weight at a compliance titrated positive end-expiratory pressure. Respiratory rate will be set to maintain normocapnia and I:E ratio set to 1:1.5 except extension of expiration is necessary in order to avoid air trapping.
Airway ventilation device
- Horowitz Index [ Time Frame: 15 minutes after chest closure ]arterial partial pressure of Oxygen (paO2) / fraction of inspired Oxygen (FiO2)
- lung tissue aeration [ Time Frame: immediately postoperative ]Lung tissue aeration assessed by Hounsfield units analysis of computed tomography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04306757
|Medical University Innsbruck|
|Innsbruck, Tyrol, Austria, 6020|
|Principal Investigator:||Judith Martini, MD||Medical University Innsbruck, Dept. of Anaesthesiology|