Patients undergoing an elective cardiac surgery procedure with intraoperative utilization of the heart-lung-maschine and perioperative ventilation.
Conditions
Interventions
Group 1: Perioperative pressure-controlled ventilation (PCV-group)
Group 2: Perioperative flow-controlled ventilation (FCV-Group, Evone®, Ventinova Medical)
Sponsors
Klinik für Anästhesiologie, Intensiv- und Schmerzmedizin Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants scheduled for an elective cardiac surgery procedure with intraoperative utilization of the heart-lung-machine and aortic cross-clamping excluding heart transplantation and any ventricular assist device implantation. Participants need to have given written informed consent into study participation on the day before the surgery.
Exclusion criteria
Exclusion criteria: Exclusion criteria: - the patient is not independently able to consent into study participation - participation in another perioperative clinical intervention study - patients with suspected or confirmed endocarditis and/or pneumonia before surgery - preoperative immunosuppresive medication. Stop criteria: - more than one cardiopulmonary bypass time due to major intraoperative complications - intraoperative death and/or cardiopulmonary resuscitation which are exclusively due to major intraoperative surgical complications - protocol deviations > 5 minutes with respect to the intervention of ventilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of interleukin 8 (IL-8) six hours after cardiopulmonary bypass (Enzyme-Linked Immunosorbent Assay, ELISA). | — |
Secondary
| Measure | Time frame |
|---|---|
| Main study: - perioperative oxygenation indices - venilation pressures - incidence of postoperative pneumonias - incidence of postoperative pulmonary complications during the first seven postoperative days - SIRS-free days during the first seven postoperative days - weaning durations - length of intensive / intermediate care unit, normal ward and total intrahospital stays Sub studies: - perioperative evaluation of parameters regarding right ventricular function in transthoracic and transoesophageal echocardiography (for example: Right ventricular Index of Myocardial Performance (RIMP) - perioperative parameters of Electrical Impedance Tomography (EIT) (for example: dorsal gradient of ventilated area) - perioperative humoral and cellular inflammation and lung injury on different levels. | — |
Countries
Germany
Contacts
Public ContactSimon Becker
Klinik für Anästhesiologie, Intensiv- und Schmerzmedizin, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
Outcome results
None listed