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

Oct 21, 2018BMJ open

Improving recovery after hip fracture in older adults by comparing spinal and general anesthesia

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Abstract

A total of 1032 patients aged over 65 will be randomised to receive either spinal or general anaesthesia for hip fracture surgery.

The primary endpoint will measure the time to the first occurrence of either all-cause mortality or new serious cardiac and pulmonary complications within 30 days after surgery.
In-hospital secondary endpoints will include mortality rates, perioperative adverse events, delirium, patient satisfaction, ability to walk independently, length of hospital stay, and discharge destination.
Long-term outcomes will be assessed through telephone interviews at 30, 180, and 365 days post-surgery, focusing on all-cause mortality, walking independence, chronic pain, cognitive function, and overall health.
The study is designed as a pragmatic, multicentre, randomised controlled trial with a parallel group approach.

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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.

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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

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