. 2018 Oct 18;8(10):e023609.

doi: 10.1136/bmjopen-2018-023609.

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

Ana Kowark¹, Christian Adam², Jörg Ahrens³, Malek Bajbouj⁴, Cornelius Bollheimer⁵, Matthias Borowski⁶, Richard Dodel⁷, Michael Dolch⁸, Thomas Hachenberg⁹, Dietrich Henzler¹⁰, Frank Hildebrand¹¹, Ralf-Dieter Hilgers¹², Andreas Hoeft¹³, Susanne Isfort¹⁴, Peter Kienbaum¹⁵, Mathias Knobe¹¹, Pascal Knuefermann¹⁶, Peter Kranke¹⁷, Rita Laufenberg-Feldmann¹⁸, Carla Nau¹⁹, Mark D Neuman²⁰, Cynthia Olotu²¹, Christopher Rex²², Rolf Rossaint¹, Robert D Sanders²³, Rene Schmidt²⁴, Frank Schneider^{25

26}, Hartmut Siebert²⁷, Max Skorning²⁸, Claudia Spies²⁹, Oliver Vicent³⁰, Frank Wappler³¹, Dieter Christian Wirtz³², Maria Wittmann¹³, Kai Zacharowski³³, Alexander Zarbock³⁴, Mark Coburn¹; iHOPE study group

Collaborators, Affiliations

Collaborators

Affiliations

¹ Department of Anaesthesiology, Medical Faculty RWTH Aachen University, Aachen, Germany.
² Department of Anaesthesiology, Intensive Care and Pain Therapy, Klinikverbund St. Antonius und St. Josef GmbH, Wuppertal, Germany.
³ Department of Anaesthesiology and Intensive Care, Medical University Hannover, Hannover, Germany.
⁴ Psychiatry and Affective Neurosciences, Campus Benjamin Franklin, Charité Center Neurology, Neurosurgery and Psychiatry, Berlin, Germany.
⁵ Department of Geriatric Medicine, Medical Faculty RWTH Aachen University, Aachen, Germany.
⁶ Institute of Biostatistics and Clinical Research, University of Muenster, Münster, Germany.
⁷ Department of Geriatrics, University Hospital Essen, Essen, Germany.
⁸ Department of Anaesthesiology, Ludwig-Maximilian University (LMU) Munich, Munich, Germany.
⁹ Department of Anaesthesiology and Intensive Care, University Hospital Magdeburg, Magdeburg, Germany.
¹⁰ Department of Anaesthesiology, Surgical Intensive Care, Emergency and Pain Medicine, Ruhr-University Bochum, Klinikum Herford, Herford, Germany.
¹¹ Department of Orthopaedic Trauma Surgery, Medical Faculty RWTH Aachen University, Aachen, Germany.
¹² Department of Medical Statistics, Medical Faculty RWTH Aachen University, Aachen, Germany.
¹³ Department of Anaesthesiology and Operative Intensive Care Medicine, University Hospital Bonn, Bonn, Germany.
¹⁴ Center for Translational & Clinical Research Aachen (CTC-A), Medical Faculty RWTH Aachen University, Aachen, Germany.
¹⁵ Department of Anaesthesiology, University Hospital Düsseldorf, Düsseldorf, Germany.
¹⁶ Department of Anaesthesiology, Gemeinschaftskrankenhaus Bonn, Bonn, Germany.
¹⁷ Department of Anaesthesiology, University Hospital Würzburg, Würzburg, Germany.
¹⁸ Department of Anaesthesiology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
¹⁹ Department of Anaesthesiology and Intensive Care, University Hospital Schleswig-Holstein, Lübeck, Germany.
²⁰ Department of Anaesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
²¹ Department of the Geriatric Anaesthesiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
²² Department of Anaesthesiology and Intensive Care, Reutlingen Hospital GMBH, Reutlingen, Germany.
²³ Department of Anesthesiology, University of Wisconsin - Madison, Madison, Wisconsin, USA.
²⁴ Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty RWTH Aachen University, Stuttgart, Germany.
²⁵ Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty RWTH Aachen University, Aachen, Germany.
²⁶ Institute for Neuroscience and Medicine (INM-10), Research Centre Jülich, Jülich, Germany.
²⁷ Aktionsbündnis Patientensicherheit e.V., Berlin, Germany.
²⁸ Section Patient Safety, Medical Advisory Service of Social Health Insurance, Essen, Germany.
²⁹ Department of Anaesthesiology, Charité Universitätsmedizin Berlin, Berlin, Germany.
³⁰ Department of Anaesthesiology and Intensive Care, University Hospital Dresden, Dresden, Germany.
³¹ Department of Anaesthesiology and Operative Intensive Care, University Witten/Herdecke, Witten/Herdecke, Germany.
³² Department of Orthopaedics and Trauma Surgery, University Hospital Bonn, Bonn, Germany.
³³ Department of Anaesthesiology, Intensive Care and Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany.
³⁴ Department of Anaesthesiology, Intensive Care and Pain Therapy, University Hospital Muenster, Muenster, Germany.

PMID: 30341135
PMCID: PMC6196806
DOI: 10.1136/bmjopen-2018-023609

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

Ana Kowark et al. BMJ Open. 2018.

. 2018 Oct 18;8(10):e023609.

doi: 10.1136/bmjopen-2018-023609.

Authors

Collaborators

Affiliations

¹ Department of Anaesthesiology, Medical Faculty RWTH Aachen University, Aachen, Germany.
² Department of Anaesthesiology, Intensive Care and Pain Therapy, Klinikverbund St. Antonius und St. Josef GmbH, Wuppertal, Germany.
³ Department of Anaesthesiology and Intensive Care, Medical University Hannover, Hannover, Germany.
⁴ Psychiatry and Affective Neurosciences, Campus Benjamin Franklin, Charité Center Neurology, Neurosurgery and Psychiatry, Berlin, Germany.
⁵ Department of Geriatric Medicine, Medical Faculty RWTH Aachen University, Aachen, Germany.
⁶ Institute of Biostatistics and Clinical Research, University of Muenster, Münster, Germany.
⁷ Department of Geriatrics, University Hospital Essen, Essen, Germany.
⁸ Department of Anaesthesiology, Ludwig-Maximilian University (LMU) Munich, Munich, Germany.
⁹ Department of Anaesthesiology and Intensive Care, University Hospital Magdeburg, Magdeburg, Germany.
¹⁰ Department of Anaesthesiology, Surgical Intensive Care, Emergency and Pain Medicine, Ruhr-University Bochum, Klinikum Herford, Herford, Germany.
¹¹ Department of Orthopaedic Trauma Surgery, Medical Faculty RWTH Aachen University, Aachen, Germany.
¹² Department of Medical Statistics, Medical Faculty RWTH Aachen University, Aachen, Germany.
¹³ Department of Anaesthesiology and Operative Intensive Care Medicine, University Hospital Bonn, Bonn, Germany.
¹⁴ Center for Translational & Clinical Research Aachen (CTC-A), Medical Faculty RWTH Aachen University, Aachen, Germany.
¹⁵ Department of Anaesthesiology, University Hospital Düsseldorf, Düsseldorf, Germany.
¹⁶ Department of Anaesthesiology, Gemeinschaftskrankenhaus Bonn, Bonn, Germany.
¹⁷ Department of Anaesthesiology, University Hospital Würzburg, Würzburg, Germany.
¹⁸ Department of Anaesthesiology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
¹⁹ Department of Anaesthesiology and Intensive Care, University Hospital Schleswig-Holstein, Lübeck, Germany.
²⁰ Department of Anaesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
²¹ Department of the Geriatric Anaesthesiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
²² Department of Anaesthesiology and Intensive Care, Reutlingen Hospital GMBH, Reutlingen, Germany.
²³ Department of Anesthesiology, University of Wisconsin - Madison, Madison, Wisconsin, USA.
²⁴ Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty RWTH Aachen University, Stuttgart, Germany.
²⁵ Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty RWTH Aachen University, Aachen, Germany.
²⁶ Institute for Neuroscience and Medicine (INM-10), Research Centre Jülich, Jülich, Germany.
²⁷ Aktionsbündnis Patientensicherheit e.V., Berlin, Germany.
²⁸ Section Patient Safety, Medical Advisory Service of Social Health Insurance, Essen, Germany.
²⁹ Department of Anaesthesiology, Charité Universitätsmedizin Berlin, Berlin, Germany.
³⁰ Department of Anaesthesiology and Intensive Care, University Hospital Dresden, Dresden, Germany.
³¹ Department of Anaesthesiology and Operative Intensive Care, University Witten/Herdecke, Witten/Herdecke, Germany.
³² Department of Orthopaedics and Trauma Surgery, University Hospital Bonn, Bonn, Germany.
³³ Department of Anaesthesiology, Intensive Care and Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany.
³⁴ Department of Anaesthesiology, Intensive Care and Pain Therapy, University Hospital Muenster, Muenster, Germany.

PMID: 30341135
PMCID: PMC6196806
DOI: 10.1136/bmjopen-2018-023609

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.

Keywords: anaesthesia in orthopaedics; anaesthetics; geriatric medicine.

PubMed Disclaimer

Conflict of interest statement

Competing interests: MC received a grant for this trial from the Federal Ministry for Education and Research (BMBF), Bonn, Germany. MDN is currently funded by the US Patient-Centered Outcomes Research Institute for related work (grant PCS 1406-18876), and he is the principal investigator of the REGAIN Trial (Clinicaltrials.gov number NCT02507505).

References

1. Anteile der Altersgruppen unter 20, ab 65 und ab 80 Jahre in Deutschland, 1871 bis 2060 (Stand: 2015. http://www.bib-demografie.de/DE/ZahlenundFakten/02/Abbildungen/a_02_12_a... (accessed March 2018).
1. Medin E, Goude F, Melberg HO, et al. . European regional differences in all-cause mortality and length of stay for patients with hip fracture. Health Econ 2015;24(Suppl 2):53–64. 10.1002/hec.3278 - DOI - PubMed
1. Royal College of Physicians and the Association of Anaesthetists of Great Britain and Ireland, 2017. National Hip Fracture Database. NHFD-AnnualReport https://nhfd.co.uk/files/2017ReportFiles/NHFD-AnnualReport2017.pdf (accessed Jun 2018).
1. Holt G, Smith R, Duncan K, et al. . Changes in population demographics and the future incidence of hip fracture. Injury 2009;40:722–6. 10.1016/j.injury.2008.11.004 - DOI - PubMed
1. Coburn M, Röhl AB, Knobe M, et al. . [Anesthesiological management of elderly trauma patients]. Anaesthesist 2016;65:98–106. 10.1007/s00101-016-0136-9 - DOI - PubMed

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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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Associated data

LinkOut - more resources

Full Text Sources

Medical

Research Materials

Miscellaneous