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
| Autor: | Kowark, Ana, Adam, Christian, Hildebrand, Frank, Hilgers, Ralf-Dieter, Hoeft, Andreas, Isfort, Susanne, Kienbaum, Peter, Knobe, Mathias, Knuefermann, Pascal, Kranke, Peter, Laufenberg-Feldmann, Rita, Nau, Carla, Ahrens, Jörg, Neuman, Mark D., Olotu, Cynthia, Rex, Christopher, Rossaint, Rolf, Sanders, Robert D., Schmidt, Rene, Schneider, Frank, Siebert, Hartmut, Skorning, Max, Spies, Claudia, Bajbouj, Malek, Vicent, Oliver, Wappler, Frank, Wirtz, Dieter Christian, Wittmann, Maria, Zacharowski, Kai, Zarbock, Alexander, Coburn, Mark, iHOPE study group, Roehl, Anna B., VanWaesberghe, Julia, Bollheimer, Cornelius, Ziemann, Sebastian, Fitzner, Christina, Batista, Joao Pedro, Freitag, Mathias, Dietrich, Claudia, Kalvelage, Christina, Grohe, Christina, Schiemann, Alexander, Schmidt, Katrin, Reichert, Dennis, Borowski, Matthias, Renziehausen, Fenja, Neumann, Claudia, Post, Fenna, Schäfer, Maximilian, Müller, Thomas, Osmers, Anne, Mersmann, Jan, Meybohm, Patrick, Kiefmann, Rainer, Riegel, Ann-Kathrin, Dodel, Richard, Koppert, Wolfgang, Reiffen, Hans-Peter, Ferner, Marion, Heid, Florian, Küllmar, Mira, Meersch, Melanie, Zwissler, Bernhard, Haas, Hansjörg, Peszko, Agneta, Ilies, Christoph, Dolch, Michael, Liener, Ulrich C., Maune, Carolin, Wehmeier, Stefanie, Helf, Antonia, Jelting, Yvonne, Hachenberg, Thomas, Henzler, Dietrich |
|---|---|
| Přispěvatelé: | iHOPE study group |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Male
medicine.medical_specialty Arthroplasty Replacement Hip Medizin Anesthesia General Anesthesia Spinal law.invention Anaesthesia 03 medical and health sciences Clinical Trial Protocols as Topic Postoperative Complications 0302 clinical medicine Randomized controlled trial 030202 anesthesiology law Pragmatic Clinical Trials as Topic Protocol Clinical endpoint Humans Multicenter Studies as Topic Medicine General anaesthesia ddc:610 030212 general & internal medicine Aged Randomized Controlled Trials as Topic Pain Postoperative Hip fracture geriatric medicine Hip Fractures business.industry Medical record anaesthesia in orthopaedics General Medicine Perioperative Middle Aged medicine.disease anaesthetics Clinical trial Telephone interview Research Design Physical therapy Female business |
| Zdroj: | BMJ open 8(10), e023609 (2018). doi:10.1136/bmjopen-2018-023609 BMJ Open |
| DOI: | 10.1136/bmjopen-2018-023609 |
| Popis: | IntroductionHip 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 analysisThe 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 disseminationiHOPE 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 numberDRKS00013644; Pre-results |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|