Article Text

Download PDFPDF

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
  1. Ana Kowark1,
  2. Christian Adam2,
  3. Jörg Ahrens3,
  4. Malek Bajbouj4,
  5. Cornelius Bollheimer5,
  6. Matthias Borowski6,
  7. Richard Dodel7,
  8. Michael Dolch8,
  9. Thomas Hachenberg9,
  10. Dietrich Henzler10,
  11. Frank Hildebrand11,
  12. Ralf-Dieter Hilgers12,
  13. Andreas Hoeft13,
  14. Susanne Isfort14,
  15. Peter Kienbaum15,
  16. Mathias Knobe11,
  17. Pascal Knuefermann16,
  18. Peter Kranke17,
  19. Rita Laufenberg-Feldmann18,
  20. Carla Nau19,
  21. Mark D Neuman20,
  22. Cynthia Olotu21,
  23. Christopher Rex22,
  24. Rolf Rossaint1,
  25. Robert D Sanders23,
  26. Rene Schmidt24,
  27. Frank Schneider25,26,
  28. Hartmut Siebert27,
  29. Max Skorning28,
  30. Claudia Spies29,
  31. Oliver Vicent30,
  32. Frank Wappler31,
  33. Dieter Christian Wirtz32,
  34. Maria Wittmann13,
  35. Kai Zacharowski33,
  36. Alexander Zarbock34,
  37. Mark Coburn1
  38. and the iHOPE study group
    1. 1 Department of Anaesthesiology, Medical Faculty RWTH Aachen University, Aachen, Germany
    2. 2 Department of Anaesthesiology, Intensive Care and Pain Therapy, Klinikverbund St. Antonius und St. Josef GmbH, Wuppertal, Germany
    3. 3 Department of Anaesthesiology and Intensive Care, Medical University Hannover, Hannover, Germany
    4. 4 Psychiatry and Affective Neurosciences, Campus Benjamin Franklin, Charité Center Neurology, Neurosurgery and Psychiatry, Berlin, Germany
    5. 5 Department of Geriatric Medicine, Medical Faculty RWTH Aachen University, Aachen, Germany
    6. 6 Institute of Biostatistics and Clinical Research, University of Muenster, Münster, Germany
    7. 7 Department of Geriatrics, University Hospital Essen, Essen, Germany
    8. 8 Department of Anaesthesiology, Ludwig-Maximilian University (LMU) Munich, Munich, Germany
    9. 9 Department of Anaesthesiology and Intensive Care, University Hospital Magdeburg, Magdeburg, Germany
    10. 10 Department of Anaesthesiology, Surgical Intensive Care, Emergency and Pain Medicine, Ruhr-University Bochum, Klinikum Herford, Herford, Germany
    11. 11 Department of Orthopaedic Trauma Surgery, Medical Faculty RWTH Aachen University, Aachen, Germany
    12. 12 Department of Medical Statistics, Medical Faculty RWTH Aachen University, Aachen, Germany
    13. 13 Department of Anaesthesiology and Operative Intensive Care Medicine, University Hospital Bonn, Bonn, Germany
    14. 14 Center for Translational & Clinical Research Aachen (CTC-A), Medical Faculty RWTH Aachen University, Aachen, Germany
    15. 15 Department of Anaesthesiology, University Hospital Düsseldorf, Düsseldorf, Germany
    16. 16 Department of Anaesthesiology, Gemeinschaftskrankenhaus Bonn, Bonn, Germany
    17. 17 Department of Anaesthesiology, University Hospital Würzburg, Würzburg, Germany
    18. 18 Department of Anaesthesiology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
    19. 19 Department of Anaesthesiology and Intensive Care, University Hospital Schleswig-Holstein, Lübeck, Germany
    20. 20 Department of Anaesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA
    21. 21 Department of the Geriatric Anaesthesiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany
    22. 22 Department of Anaesthesiology and Intensive Care, Reutlingen Hospital GMBH, Reutlingen, Germany
    23. 23 Department of Anesthesiology, University of Wisconsin – Madison, Madison, Wisconsin, USA
    24. 24 Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty RWTH Aachen University, Stuttgart, Germany
    25. 25 Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty RWTH Aachen University, Aachen, Germany
    26. 26 Institute for Neuroscience and Medicine (INM-10), Research Centre Jülich, Jülich, Germany
    27. 27 Aktionsbündnis Patientensicherheit e.V., Berlin, Germany
    28. 28 Section Patient Safety, Medical Advisory Service of Social Health Insurance, Essen, Germany
    29. 29 Department of Anaesthesiology, Charité Universitätsmedizin Berlin, Berlin, Germany
    30. 30 Department of Anaesthesiology and Intensive Care, University Hospital Dresden, Dresden, Germany
    31. 31 Department of Anaesthesiology and Operative Intensive Care, University Witten/Herdecke, Witten/Herdecke, Germany
    32. 32 Department of Orthopaedics and Trauma Surgery, University Hospital Bonn, Bonn, Germany
    33. 33 Department of Anaesthesiology, Intensive Care and Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany
    34. 34 Department of Anaesthesiology, Intensive Care and Pain Therapy, University Hospital Muenster, Muenster, Germany
    1. Correspondence to Dr Mark Coburn; mcoburn{at}ukaachen.de

    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

    • anaesthetics
    • geriatric medicine
    • anaesthesia in orthopaedics

    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/.

    View Full Text

    Statistics from Altmetric.com

    Footnotes

    • Contributors MC is the iHOPE Study Director and Coordinating Principal Investigator. He conceived the overall study and received the iHOPE grant (01KG1714 from the Federal Ministry for Education and Research (BMBF), Bonn, Germany). The iHOPE Clinical Project Management is allocated to AK. AK wrote the first draft of this manuscript and made substantial contributions to the conception of the study protocol together with MC. The iHOPE Trial Management (MC, RR, SI, AH and MDN), the Trial Statistician (R-DH), the Data Monitoring and Safety Board (CN, TH, DH, MalB, MatB and RD), the investigators of the participating iHOPE centres (CA, JA, MD, PetK, PasK, PetK, RL-F, CO, CR, RS, CS, OV, FW, MW, KZ and AZ) and other participating bodies (FH, HS, MS, DCW, MK, FS, CB and RDS) each made substantial contributions to the conception or design of the study protocol. All authors revised the protocol critically for important intellectual content, approved the final version and agree to be accountable for all aspects of the work. The iHOPE study group is listed as Collaborators. The Collaborators are substantially involved in carrying out the iHOPE study as Investigators of the recruiting centres, in the project and data management and monitoring. All Collaborators critically reviewed the study protocol and the manuscript.

    • Funding This work was supported by the Federal Ministry for Education and Research (BMBF), Bonn, Germany (grant number 01KG1714).

    • 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).

    • Patient consent Not required.

    • Ethics approval Ethical approval EK 022/18 was obtained from the leading Ethics Committee of the RWTH Aachen University on 14 March 2018. An approval from all other involved local ethical committees was subsequently requested.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Collaborators Anna B Roehl, Julia Van Waesberghe and Sebastian Ziemann, Department of Anaesthesiology, Medical Faculty RWTH Aachen University, Aachen, Germany. Christina Fitzner, Department of Medical Statistics, Medical Faculty RWTH Aachen University, Aachen, Germany. Joao Pedro Batista and Mathias Freitag, Department of Geriatric Medicine, Medical Faculty RWTH Aachen University, Aachen, Germany. Dr Claudia Dietrich, Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty RWTH Aachen University, Aachen, Germany. Christina Kalvelage and Christina Grohe, Center for Translational & Clinical Research Aachen (CTC-A), Medical Faculty RWTH Aachen University, Aachen, Germany. Alexander Schiemann and Katrin Schmidt, Department of Anaesthesiology, Charité Universitätsmedizin Berlin, Berlin, Germany. Dennis Reichert and Fenja Renziehausen, Department of Anaesthesiology, Gemeinschaftskrankenhaus Bonn, Bonn, Germany. Claudia Neumann, Department of Anaesthesiology and Operative Intensive Care Medicine, University Hospital Bonn, Bonn, Germany. Fenna Post and Maximilian Schäfer, Department of Anaesthesiology, University Hospital Düsseldorf, Düsseldorf, Germany. Thomas Müller and Anne Osmers, Department of Anaesthesiology and Intensive Care, University Hospital Dresden, Dresden, Germany. Jan Mersmann and Patrick Meybohm, Department of Anaesthesiology, Intensive Care and Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany. Rainer Kiefmann and Ann-Kathrin Riegel, Department of the Geriatric Anaesthesiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. Wolfgang Koppert and Hans-Peter Reiffen, Department of Anaesthesiology and Intensive Care, Medical University Hannover, Hannover, Germany. Marion Ferner and Florian Heid, Department of Anaesthesiology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany. Mira Küllmar and Melanie Meersch, Department of Anaesthesiology, Intensive Care and Pain Therapy, University Hospital Muenster, Muenster, Germany. Bernhard Zwissler, Department of Anaesthesiology, Ludwig-Maximilian University (LMU) Munich, Munich, Germany. Hansjörg Haas and Agneta Peszko, Department of Anaesthesiology and Intensive Care, Reutlingen Hospital GMBH, Reutlingen, Germany. Christoph Ilies and Ulrich C Liener, Department of Anaesthesiology, Intensive Care and Pain Therapy, Marienhospital Stuttgart, Stuttgart, Germany. Carolin Maune and Stefanie Wehmeier Department of Anaesthesiology and Operative Intensive Care, University Witten/Herdecke. Tim Koke and Ingo Schwartges, Department of Anaesthesiology, Intensive Care and Pain Therapy, Klinikverbund St. Antonius und St. Josef GmbH, Wuppertal, Germany. Antonia Helf and Yvonne Jelting, Department of Anaesthesiology, University Hospital Würzburg, Würzburg, Germany.

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.