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

TY - JOUR

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

AU - Kowark, Ana

AU - Adam, Christian

AU - Ahrens, Jörg

AU - Bajbouj, Malek

AU - Bollheimer, Cornelius

AU - Borowski, Matthias

AU - Dodel, Richard

AU - Dolch, Michael

AU - Hachenberg, Thomas

AU - Henzler, Dietrich

AU - Hildebrand, Frank

AU - Hilgers, Ralf-Dieter

AU - Hoeft, Andreas

AU - Isfort, Susanne

AU - Kienbaum, Peter

AU - Knobe, Mathias

AU - Knuefermann, Pascal

AU - Kranke, Peter

AU - Laufenberg-Feldmann, Rita

AU - Nau, Carla

AU - Neuman, Mark D

AU - Olotu, Cynthia

AU - Rex, Christopher

AU - Rossaint, Rolf

AU - Sanders, Robert D

AU - Schmidt, Rene

AU - Schneider, Frank

AU - Siebert, Hartmut

AU - Skorning, Max

AU - Spies, Claudia

AU - Vicent, Oliver

AU - Wappler, Frank

AU - Wirtz, Dieter Christian

AU - Wittmann, Maria

AU - Zacharowski, Kai

AU - Zarbock, Alexander

AU - Coburn, Mark

AU - Roehl, Anna B

AU - van Waesberghe, Julia

AU - Ziemann, Sebastian

AU - Fitzner, Christina

AU - Batista, Joao Pedro

AU - Freitag, Mathias

AU - Dietrich, Claudia

AU - Kalvelage, Christina

AU - Grohe, Christina

AU - Schiemann, Alexander

AU - Schmidt, Katrin

AU - Reichert, Dennis

AU - Renziehausen, Fenja

AU - Neumann, Claudia

AU - Post, Fenna

AU - Schaefer, Maximilian

AU - Müller, Thomas

AU - Osmers, Anne

AU - Mersmann, Jan

AU - Meybohm, Patrick

AU - Kiefmann, Rainer

AU - Riegel, Ann-Kathrin

AU - Koppert, Wolfgang

AU - Reiffen, Hans-Peter

AU - Ferner, Marion

AU - Heid, Florian

AU - Kuellmar, Mira

AU - Meersch, Melanie

AU - Zwissler, B

AU - Haas, H

AU - Peszko, Agneta

AU - Illies, Christoph

AU - Liener, Ulrich

AU - Maune, Carolin

AU - Wehmeier, Stefanie

AU - Koke, Tim

AU - Schwartges, Ingo

AU - Helf, Antonia

AU - Jelting, Yvonne

AU - iHOPE study group

N1 - © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2018/10/18

Y1 - 2018/10/18

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.

AB - 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 - Journal Article

U2 - 10.1136/bmjopen-2018-023609

DO - 10.1136/bmjopen-2018-023609

M3 - SCORING: Journal article

C2 - 30341135

VL - 8

SP - e023609

JO - BMJ OPEN

JF - BMJ OPEN

SN - 2044-6055

IS - 10

ER -