Improve hip fracture outcome in the elderly patient (iHOPE) : a study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia

  • Introduction: Hip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse. Methods and analysis: The iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 patients with hip fracture (>65 years) will be randomised in an intended 1:1 allocation ratio to receive spinal anaesthesia (n=516) or general anaesthesia (n=516). Outcome assessment will occur in a blinded manner after hospital discharge and inhospital. The primary endpoint will be assessed by telephone interview and comprises the time to the first occurring event of the binary composite outcome of all-cause mortality or new-onset serious cardiac and pulmonary complications within 30 postoperative days. In-hospital secondary endpoints, assessed via in-person interviews and medical record review, include mortality, perioperative adverse events, delirium, satisfaction, walking independently, length of hospital stay and discharge destination. Telephone interviews will be performed for long-term endpoints (all-cause mortality, independence in walking, chronic pain, ability to return home cognitive function and overall health and disability) at postoperative day 30±3, 180±45 and 365±60. Ethics and dissemination: iHOPE has been approved by the leading Ethics Committee of the Medical Faculty of the RWTH Aachen University on 14 March 2018 (EK 022/18). Approval from all other involved local Ethical Committees was subsequently requested and obtained. Study started in April 2018 with a total recruitment period of 24 months. iHOPE will be disseminated via presentations at national and international scientific meetings or conferences and publication in peer-reviewed international scientific journals. Trial registration number: DRKS00013644; Pre-results
Metadaten
Author:Ana Kowark, Christian Adam, Jörg Ahrens, Malek Bajbouj, Cornelius Bollheimer, Matthias Borowski, Richard Dodel, Michael Dolch, Thomas Hachenberg, Dietrich Henzler, Frank Hildebrand, Ralf-Dieter Hilgers, Andreas Hoeft, Susanne Isfort, Peter Kienbaum, Mathias Knobe, Pascal Knüfermann, Peter Kranke, Rita Laufenberg-Feldmann, Carla Nau, Mark D. Neuman, Cynthia Olotu, Christopher Rex, Rolf Rossaint, Robert D. Sanders, Rene Schmidt, Frank Schneider, Hartmut Siebert, Max Skorning, Claudia Spies, Oliver Vicent, Frank Wappler, Dieter Christian Wirtz, Maria Wittmann, Kai ZacharowskiORCiDGND, Alexander Zarbock, Mark Coburn
URN:urn:nbn:de:hebis:30:3-477118
DOI:https://doi.org/10.1136/bmjopen-2018-023609
ISSN:2044-6055
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/30341135
Parent Title (English):BMJ open
Publisher:BMJ Publishing Group
Place of publication:London
Document Type:Article
Language:English
Year of Completion:2018
Date of first Publication:2018/10/18
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Contributing Corporation:iHOPE study group
Release Date:2018/10/23
Tag:anaesthesia in orthopaedics; anaesthetics; geriatric medicine
Volume:8
Issue:10, e023609
Page Number:11
First Page:1
Last Page:11
Note:
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
HeBIS-PPN:439102251
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (English):License LogoCreative Commons - Namensnennung-Nicht kommerziell 4.0