Perioperative FLOW-controlled VENTilation (FCV) versus pressure-controlled ventilation (PCV) IN on-pump HEART SURGery: A prospective randomized-controlled clinical trial
Organizational Data
- DRKS-ID:
- DRKS00018956
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-06-12
- Last update in DRKS:
- 2023-06-12
- Registration type:
- Prospective
Acronym/abbreviation of the study
FLOWVENTIN HEARTSURG
URL of the study
No Entry
Brief summary in lay language
Cardiac surgery during general anaesthesia requires mechanical ventilation of the lungs. So far mechanical ventilation is either volume- or pressure-controlled. Ventilation und the utilization of a heart-lung-machine during cardiac surgery cause inflammation in the lungs and the whole body. Flow-controlled ventilation is a new mode of mechanical ventilation. Compared to volume- and pressure-controlled ventilation in- and also expiration can be controlled by a steady and continuous gas flow. This might stress the lungs less. In this research project we propose that flow-controlled ventilation during cardiac surgery procedures with a heart-lung-maschine reduces the degree of inflammation compared to pressure-controlled ventilation. For this purpose 140 patients in total are scheduled to be ventilated either in a flow- or pressure-controlled mode before, during and after heart surgery with an allocation ratio of 1:1. Inflammatory parameters in the blood are measured before, during and after surgery. Also the function of the heart, lungs and kidneys are assessed during and after the procedure. Every patient at the age of 18 or older with a scheduled heart operation and intraoperative utilization of the heart-lung-machine can participate in the study.
Brief summary in scientific language
Flow-controlled ventilation (FCV) is a new mode of mechanical lung ventilation. During inspiration lungs are filled with a constant and continous low gas flow. Expiration is facilitated with the same (negative) gas flow using the Bernoulli effect. This new mode of ventilation might reduce ventilator-induced lung injury compared to conventional pressure- and volume-controlled ventilation by minimizing the dissipated energy of mechanical ventilation [1]. During cardiac surgery with a heart-lung-machine (HLM) in general anaesthesia lungs are mechanically ventilated before, during and after the procedure. The HLM mimics the heart and lung funtion and includes a temporary bypass of the pulmonary and cardiac circulation (cardiopulmonary bypass). While heart and lungs are ischemic during this period the actual surgery on the non-beating heart can be performed without the need for mechanical ventilation. Termination of the cardiopulmonary bypass after the procedure means reperfusion of the pulmonary (and heart) circulation. The sequence of ischemia and reperfusion causes a specific lung injury by humoral and cellular inflammatory cascades and is well described as ischemia-reperfusion-induced lung injury [2, 3]. The hypothesis of the study is that the perioperative use of flow-controlled ventilation reduces the pulmonary and systemic inflammation in cardiac surgery patients after cardiopulmonary bypass compared to conventional pressure-controlled ventilation (PCV). In a prospective randomized-controlled trial patients (n=128) with elective cardiac surgery and intraoperative utilization of the HLM (on-pump) are either flow- (n=64) or pressure-controlled (n=64) ventilated before, during and after the procedure. The primary endpoints of the study is the plasmatic IL-8 concentration six hours after termination of the cardiopulmonary bypass as a surrogate biomarker of pulmonary and systemic inflammation. In different explorative sub studies the perioperative effect of FCV versus PCV on (1) right ventricular funtion parameters before and after cardiopulmonary bypass (n=35/group), (2) different humoral and cellular inflammation cascades (n=35/group) and (3) the perioperative distributation of air using electrical impedance tomography (EIT) (n=50/group) is assessed. [1] Barnes T, van Asseldonk D, Enk D. Minimisation of dissipated energy in the airways during mechanical ventilation by using constant inspiratory and expiratory flows - Flow-controlled ventilation (FCV). Med Hypotheses 2018;121:167-76. [2] Massoudy P, Zahler S, Becker BF, Braun SL, Barankay A, Meisner H. Evidence for inflammatory responses of the lungs during coronary artery bypass grafting with cardiopulmonary bypass. Chest 2001;119:31-6. [3] de Perrot M, Liu M, Waddell TK, Keshavjee S. Ischemia-reperfusion-induced lung injury. Am J Respir Crit Care Med 2003;167:490-511. The study amendment from 17/05/2021 was approved by the Ethics Committee of the Medical Faculty, Ruhr-University Bochum, on the 29/07/2021 (Registrier-Nr: 19-6740-§ 23b) and contained mainly the following: The study title has been changed with respect to the perioperative approach of the study; the primary endpoint of the study has been changed to one surrogate biomarker at one postoperative time point due to statistical reasons without changing the total number of participants or the group size; the secondary endpoints of the main study and the sub studies have been modified; the inclusion and exclusion criteria as well as study termination criteria have been modified; ventilation is individualized in both groups according to the study protocol. The study amendment II from 16/03/2022 was approved by the Ethics Committee of the Medical Faculty, Ruhr-University Bochum, on the 23/03/2022 (Registrier-Nr: 19-6740-§ 23b) and contained the following: Amendments of the study inclusion and study termination criteria. Due to these discontinuation rates are expected to be 10 % resulting in a total number of 140 patients being recruited and randomized for the study.
Health condition or problem studied
- Free text:
- Patients undergoing an elective cardiac surgery procedure with intraoperative utilization of the heart-lung-maschine and perioperative ventilation.
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Perioperative pressure-controlled ventilation (PCV-group)
- Arm 2:
- Perioperative flow-controlled ventilation (FCV-Group, Evone®, Ventinova Medical)
Endpoints
- Primary outcome:
- Plasma concentration of interleukin 8 (IL-8) six hours after cardiopulmonary bypass (Enzyme-Linked Immunosorbent Assay, ELISA).
- Secondary outcome:
- 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.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- III
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil; Klinik für Anästhesiologie, Intensiv- und Schmerzmedizin Bochum
Recruitment period and number of participants
- Planned study start date:
- 2020-07-01
- Actual study start date:
- 2020-08-10
- Planned study completion date:
- 2023-05-16
- Actual Study Completion Date:
- 2023-05-16
- Target Sample Size:
- 140
- Final Sample Size:
- 140
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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: - 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
Addresses
Primary Sponsor
- Address:
- Klinik für Anästhesiologie, Intensiv- und Schmerzmedizin Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbHProf. Dr. med. Peter ZahnBürkle-de-la-Camp-Platz 144789 BochumGermany
- Telephone:
- +49 - 234 - 302 6825
- Fax:
- +49 - 234 - 302 6834
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://bergmannsheil.bg-kliniken.de/behandlungsspektrum/anaesthesiologie-intensiv-und-schmerzmedizin/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinik für Anästhesiologie, Intensiv- und Schmerzmedizin Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbHDr. med. Simon BeckerBürkle-de-la-Camp-Platz 144789 BochumGermany
- Telephone:
- +49 - 234 - 302 6917
- Fax:
- +49 - 234 - 302 6834
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://bergmannsheil.bg-kliniken.de/behandlungsspektrum/anaesthesiologie-intensiv-und-schmerzmedizin/
Contact for Public Queries
- Address:
- Klinik für Anästhesiologie, Intensiv- und Schmerzmedizin, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbHDr. med. Simon BeckerBürkle-de-la-Camp-Platz 144789 BochumGermany
- Telephone:
- +49 - 234 - 302 6917
- Fax:
- +49 - 234 - 302 6834
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://bergmannsheil.bg-kliniken.de/behandlungsspektrum/anaesthesiologie-intensiv-und-schmerzmedizin/
Principal Investigator
- Address:
- Klinik für Anästhesiologie, Intensiv- und Schmerzmedizin Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbHDr. med. Simon BeckerBürkle-de-la-Camp-Platz 144789 BochumGermany
- Telephone:
- +49 - 234 - 302 6917
- Fax:
- +49 - 234 - 302 6834
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://bergmannsheil.bg-kliniken.de/behandlungsspektrum/anaesthesiologie-intensiv-und-schmerzmedizin/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Forschungsreferat Medizinische Fakultät Ruhr-Universität BochumUniversitätsstraße 15044801 BochumGermany
- Telephone:
- +49 (0) 234 - 32 25585
- Fax:
- +49 (0) 234 - 32 14381
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.medizin.ruhr-uni-bochum.de/forschung/foerderung.html.de
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinik für Anästhesiologie, Intensiv- und Schmerzmedizin Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbHBürkle-de-la-Camp-Platz 144789 BochumGermany
- Telephone:
- +49 - 234 - 302 6825
- Fax:
- +49 - 234 - 302 6834
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://bergmannsheil.bg-kliniken.de/behandlungsspektrum/anaesthesiologie-intensiv-und-schmerzmedizin/
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität BochumGesundheitscampus 3344801 BochumGermany
- Telephone:
- +49-234-79816555
- Fax:
- +49-234-79816556
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-09-24
- Ethics committee number:
- 19-6740-§23b
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-06-03
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- Before the enrolment of the last participant the study protocol is supposed to be published in an appropriate journal after peer-reviewing. After pseudonymisation, data is transferred and processed with the web-based application REDCap™. This enables data sharing with the scientific community.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Becker S, Schnitzler R, Rembecki M, Geppert J, Kurz CT, Wichelhaus LM, Timmesfeld N, Zahn PK. Individualized flow-controlled versus conventional pressure-controlled ventilation in on-pump heart surgery (FLOWVENTIN HEARTSURG): study protocol for a randomized controlled trial. Trials 2023;24:195. doi: 10.1186/s13063-023-07201-7.
- Date of first publication of study results:
- 2023-03-16
- DRKS entry published for the first time with results:
- 2023-06-12
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry