TY  - JOUR
A1  - Kowark, Ana
A1  - Adam, Christian
A1  - Ahrens, Jörg
A1  - Bajbouj, Malek
A1  - Bollheimer, Cornelius
A1  - Borowski, Matthias
A1  - Dodel, Richard
A1  - Dolch, Michael
A1  - Hachenberg, Thomas
A1  - Henzler, Dietrich
A1  - Hildebrand, Frank
A1  - Hilgers, Ralf-Dieter
A1  - Hoeft, Andreas
A1  - Isfort, Susanne
A1  - Kienbaum, Peter
A1  - Knobe, Mathias
A1  - Knüfermann, Pascal
A1  - Kranke, Peter
A1  - Laufenberg-Feldmann, Rita
A1  - Nau, Carla
A1  - Neuman, Mark D.
A1  - Olotu, Cynthia
A1  - Rex, Christopher
A1  - Rossaint, Rolf
A1  - Sanders, Robert D.
A1  - Schmidt, Rene
A1  - Schneider, Frank
A1  - Siebert, Hartmut
A1  - Skorning, Max
A1  - Spies, Claudia
A1  - Vicent, Oliver
A1  - Wappler, Frank
A1  - Wirtz, Dieter Christian
A1  - Wittmann, Maria
A1  - Zacharowski, Kai
A1  - Zarbock, Alexander
A1  - Coburn, Mark
T1  - 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
T2  - BMJ open
N2  - 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
KW  - anaesthesia in orthopaedics
KW  - anaesthetics
KW  - geriatric medicine
Y1  - 2018
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/47711
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-477118
SN  - 2044-6055
N1  - 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/.
VL  - 8
IS  - 10, e023609
SP  - 1
EP  - 11
PB  - BMJ Publishing Group
CY  - London
ER  -