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| Name | Class |
|---|---|
| Ventinova | UNKNOWN |
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The goal of this clinical trial is to study the effects of Flow Controlled Ventilation (FCV) following conventional mechanical ventilation (Pressure or Volume Controlled Ventilation) in postcardiac surgery ICU-patients to allow for future power calculations and to obtain experience with FCV.
The main questions it aims to answer are:
Participants will be ventilated with PCV at baseline and then switched to FCV for 90 minutes while the lung volume, minute volume and mechanical power and dissipated energy levels are measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postcardiac surgery ICU-patients | Experimental | After postcardiac surgery patients are brought to the ICU and are ventilated on PCV (Pressure Controlled Ventilation). Measurements of the lung volume (by Electrical Impedance Tomography; EIT), the minute volume and Mechanical Power/Dissipated energy are started and continued for the duration of the study. After a few minutes the patient is switched to FCV (Flow Controlled Ventilation) for 90 minutes and afterwards PCV is resumed with the measurements lasting for another 30 minutes (total study time 120 minutes). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flow Controlled Ventilation (FCV) | Device | FCV is started with the same settings as PCV (PEEP, Ppeak, FiO2) and after 30 minutes FCV is optimized concerning the driving pressure and PEEP using the dynamic compliance. After a total of 60 minutes the flow is adjusted based on the arterial blood gas. |
| Measure | Description | Time Frame |
|---|---|---|
| End-expiratory lung volume | The difference in End-expiratory lung volume (EELV) between PCV and FCV is measured using the difference in End-expiratory lung impedance (EELI) and tidal volume at baseline | Baseline EELV compared to after 30 minutes of FCV (same ventilator settings) |
| Measure | Description | Time Frame |
|---|---|---|
| Minute volume | The difference in minute volume between PCV and FCV with a stable PaCO2 | The difference in minute volume between PCV at baseline and after 90 minutes of FCV (after optimization of FCV) |
| Mechanical Power |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Endeman, MD, PhD | Erasmus MC, Rotterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Rotterdam | South Holland | 3015 GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38502268 | Derived | Van Oosten JP, Francovich JE, Somhorst P, van der Zee P, Endeman H, Gommers DAMPJ, Jonkman AH. Flow-controlled ventilation decreases mechanical power in postoperative ICU patients. Intensive Care Med Exp. 2024 Mar 19;12(1):30. doi: 10.1186/s40635-024-00616-9. |
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PCV at baseline, followed by 90 minutes of FCV and finished with 30 minutes of PCV
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The difference in Mechanical Power between PCV and FCV are measured by using our own produced Pressure-Volume loops
| The difference in Mechanical Power between PCV at baseline and after 90 minutes of FCV (after FCV optimization) |
| Dissipated energy | The difference in Dissipated energy between PCV and FCV are measured by using our own produced Pressure-Volume loops | The difference in Dissipated energy between PCV at baseline and after 90 minutes of FCV (after FCV optimization) |