Perioperative FLOW-controlled VENTilation (FCV) versus pressure-controlled ventilation (PCV) IN on-pump HEART SURGery: A prospective randomized-controlled clinical trial
- Conditions
- Patients undergoing an elective cardiac surgery procedure with intraoperative utilization of the heart-lung-maschine and perioperative ventilation.
- Registration Number
- DRKS00018956
- Lead Sponsor
- Klinik für Anästhesiologie, Intensiv- und Schmerzmedizin Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 140
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.
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration of interleukin 8 (IL-8) six hours after cardiopulmonary bypass (Enzyme-Linked Immunosorbent Assay, ELISA).
- Secondary Outcome Measures
Name Time Method Main study:<br>- perioperative oxygenation indices<br>- venilation pressures<br>- incidence of postoperative pneumonias<br>- incidence of postoperative pulmonary complications during the first seven postoperative days<br>- SIRS-free days during the first seven postoperative days<br>- weaning durations<br>- length of intensive / intermediate care unit, normal ward and total intrahospital stays<br><br>Sub studies:<br>- perioperative evaluation of parameters regarding right ventricular function in transthoracic and transoesophageal echocardiography (for example: Right ventricular Index of Myocardial Performance (RIMP)<br>- perioperative parameters of Electrical Impedance Tomography (EIT) (for example: dorsal gradient of ventilated area)<br>- perioperative humoral and cellular inflammation and lung injury on different levels.