ETHICS APPROVAL AND CONSENT TO PARTICIPATE
This trial was performed in accordance with the Declaration of Helsinki and was approved by the local ethics board (Ethics Committee of Charité-Universitätsmedizin Berlin) – registration number: EA1/348/14.
All patients gave written informed consent, prior to entering the study.
CONSENT FOR PUBLICATION
Not applicable
AVAILABILITY OF DATA AND MATERIALS
The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. The complete trial protocol for this investigator-initiated trial is available in German only and can be requested by the corresponding author.
COMPETING INTERESTS
PN, TB, SC, AB, JS, MB, AH have no conflict of interest. LK reports grants from 3 M during the conduct of the study; personal fees from HICC Deutschland GbR., Novo Nordisk, Sintetica, CSL Behring, outside the submitted work. CvH reports personal fees from Bayer AG, CSL Behring, Boehringer Ingelheim, Pfizer GmbH, Bristol Myers Squibb, Shire, Ferring GmbH, Sanofi Aventis, Mitsubishi Pharma, Novo Nordisk, HICC GbR, grants and personal fees from Daiichi Sankyo, outside the submitted work.
CS received funding from European Union funded seventh framework research program (FP7/2007-2013), under the grant agreement No. HEALTH-F2-2014-60246, Bio Cog, grants from Dr. Köhler Chemie GmbH, AppAdventure, J&P Medical Research Ltd., Pharmaceutical Research Associate GmbH, Delcath Systems Inc., INC Research UK Ltd, La Jolla Pharmaceutical Company, ARIDIS Pharmaceutical Inc., B.Braun Melsungen AG, Drägerwerk AG & CoKGaA, Grünenthal GmbH, Infectopharm GmbH, Sedana Medical Ltd., Arbeitsgemeinschaft industrieller Forschungsvereinigungen “Otto von Guericke” e.V. (AiF) / German Federation of Industrial Research Associations, Berufsverband deutscher Anästhesisten e.V. (BDA)/ Professional Associationof German Anaesthesiologists, Deutsche Forschungsgemeinschaft/ German Research Society, Deutsches Zentrum für Luft- und Raumfahrttechnik e.V. (DLR)/German Aerospace Center, Einstein Stiftung Berlin/Einstein Foundation Berlin, European Society of Anaesthesiology, Gemeinsamer Bundesausschuss/Federal Joint Commitee (G-BA), inneruniversitäre Forschungsförderung/Inner university grant, Projektträger im DLR/Project Management Agency, Stifterverband/Non-Profit Society Promoting Science and Education, WHOCC, Westfälische Wilhelms- Universität Münster/DFG, AbbVie Deutschland GmbH & CoKG, Aguettant Deutschland GmbH, MAQUET Vertrieb und Service Deutschland GmbH, Orion Pharma GmbH, Philips Electronics Nederland B.V., Sintetica GmbH,
Baxter Deutschland GmbH, Biotest AG, Cytosorbents Europe GmbH, Edwards Lifesciences Germany GmbH, Fresenius Medical Care, Masimo Europe Ltd., Medtronic GmbH, Pfizer Pharma PFE GmbH, European Commission, BMUB (Bundesministerium für Umwelt, Naturschutz und nukleare Sicherheit),
personal fees from B.Braun Melsungen AG, Georg Thieme Verlag; outside the submitted work. CS has a patent 10 2014 215 211.9 pending, a patent application No. PCT/EP2015/067730 pending to Graft Gesellschaft von Architekten mbH and a patent application No. PCT/EP2015/067731 pending to Graft Gesellschaft von Architekten mbH.
All authors report no conflict of interest relating to this work.
FUNDING
This investigator initiated trial was funded by 3M Deutschland GmbH without any involvement of the funding body on study design, data collection, analysis, interpretation of data and in writing the manuscript. The corresponding author had full access to all study data.
AUTHORS CONTRIBUTION
Substantial contributions to conception and design: LK, CvH, PN
Acquisition of data: PN, TB, SC, MB
Analysis and Interpretation of data: AB, JS, MB, CS, AH, CvH
Drafting the manuscript: LK, AB
Revision of the manuscript: PN, TB, SC, JS, MB, CS, AH, CvH
Final approval: LK, PN, TB, SC, JS, AB, MB, CS, AH, CvH
Agreement to be accountable for all aspects of the work: LK, PN, TB, SC, JS, AB, MB, CS, AH, CvH
All Authors meet the criteria for authorship according to the ICMJE guidelines.
ACKNOWLEDGEMENTS
Not applicable
STUDY PRESENTATION
This trial was presented in parts at the annual meetings of the American Society of Anesthesiologists 2017 and the European Society of Anesthesiology 2018.