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. Issue 10 (18th October 2018)

• Record Type: Journal Article
• Authors: Kowark, Ana; Adam, Christian; Ahrens, Jörg; Bajbouj, Malek; Bollheimer, Cornelius; Borowski, Matthias; Dodel, Richard; Dolch, Michael; Hachenberg, Thomas; Henzler, Dietrich; Hildebrand, Frank; Hilgers, Ralf-Dieter; Hoeft, Andreas; Isfort, Susanne; Kienbaum, Peter; Knobe, Mathias; Knuefermann, Pascal; Kranke, Peter; Laufenberg-Feldmann, Rita; Nau, Carla; Neuman, Mark D; Olotu, Cynthia; Rex, Christopher; Rossaint, Rolf; Sanders, Robert D; Schmidt, Rene; Schneider, Frank; Siebert, Hartmut; Skorning, Max; Spies, Claudia; Vicent, Oliver; Wappler, Frank; Wirtz, Dieter Christian; Wittmann, Maria; Zacharowski, Kai; Zarbock, Alexander; Coburn, Mark;
• Other Names: author non-byline.; Roehl Anna B author non-byline.; Waesberghe Julia Van author non-byline.; Ziemann Sebastian author non-byline.; Fitzner Christina author non-byline.; Batista Joao Pedro author non-byline.; Freitag Mathias author non-byline.; Dietrich Claudia author non-byline.; Kalvelage Christina author non-byline.; Grohe Christina author non-byline.; Schiemann Alexander author non-byline.; Schmidt Katrin author non-byline.; Reichert Dennis author non-byline.; Renziehausen Fenja author non-byline.; Neumann Claudia author non-byline.; Post Fenna author non-byline.; Schäfer Maximilian author non-byline.; Müller Thomas author non-byline.; Osmers Anne author non-byline.; Mersmann Jan author non-byline.; Meybohm Patrick author non-byline.; Kiefmann Rainer author non-byline.; Riegel Ann-Kathrin author non-byline.; Koppert Wolfgang author non-byline.; Reiffen Hans-Peter author non-byline.; Ferner Marion author non-byline.; Heid Florian author non-byline.; Küllmar Mira author non-byline.; Meersch Melanie author non-byline.; Zwissler Bernhard author non-byline.; Haas Hansjörg author non-byline.; Peszko Agneta author non-byline.; Ilies Christoph author non-byline.; Liener Ulrich C author non-byline.; Maune Carolin author non-byline.; Wehmeier Stefanie author non-byline.; Helf Antonia author non-byline.; Jelting Yvonne author non-byline.;
• Is Part Of: BMJ open. Volume 8:Issue 10(2018)
• Publication Date: 2018-10-18
• Subjects: anaesthetics -- geriatric medicine -- anaesthesia in orthopaedics; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2018-023609
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : 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