Specialty: Injuries and emergencies, Primary sub-specialty: Injuries and emergencies
Conditions
Interventions
The REGARD study is a feasibility randomised control trial (RCT). REGARD is a small trial (n=100) looking to recruit patients aged over 65, who are about to undergo surgery for a fractured hip and are
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinically or radiographically diagnosed intracapsular or extracapsular hip fracture 2. Planned surgical treatment via hemiarthroplasty, total hip arthroplasty or appropriate fixation procedure 3. Aged 65 years and over
Exclusion criteria
Exclusion criteria: 1. Multiple trauma or planned concurrent surgery not amenable to spinal anaesthesia 2. Absolute contraindication to regional anaesthesia: 2.1. Known or suspected congenital or acquired coagulopathy 2.2. Active use of pharmacological anticoagulants within a timeframe defined to contraindicate neuraxial block placement 2.3. Known or suspected unrepaired critical or severe aortic stenosis 2.4. Known or suspected active skin infection at the planned needle insertion site 2.5. Known or suspected elevated intracranial pressure contraindicating dural puncture; previous spinal surgery precluding RA, localised sepsis in lumbar spine, documented allergies to local anaesthetic 3. Known or suspected to be at elevated risk for malignant hyperthermia 4. Previous participation in the REGARD trial 5. Determination by the surgeon or the anaesthetist that the patient would not be suitable for randomisation 6. Patient not expected to survive beyond 48 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of eligible patients that are randomised are measured using records at study end 2. Proportion of patients/consultees providing agreement to ongoing study participation is measured using study records at end of study 3. Proportion of patients with complete follow-up data are measured suing study record at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 01/06/2021: Secondary feasibility outcomes: 1. Proportion of patients/consultees providing assent to ongoing study participation is measured using study records at end of study 2. Proportion of patients with complete follow-up data are measured using study record at the end of the study Secondary patient outcomes: 1. Number of patients who develop post-operative delirium within 7 days using face to face delirium screening tools (4A Tests, Richmond Agitation Sedation Scale, Abbreviate Mental Test Score) or medical notes review on Day 1, Day 2 and Day 7 2. Severity of post-operative delirium if present is measured using Memorial Delirium Assessment Scale (MDAS) on Day 1, Day 2 and Day 7 3. Acute pain using analgesic use and prescription chart review on Day 1, Day 2 and Day 7 4. Cognitive function is measured using Mini Addenbrookes Cognitive Examination (MACE, if patient completes) on Day of discharge. Cognitive Function is also collected using MACE or Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE, if family/friend completes) on 120 day follow up 5. Post-operative complications is measured using Post-operative Morbidity Survey-Hip Fracture and medical notes review on Day 1, Day 2 and Day 7 6. Persistent delirium is screened using delirium screening tools and MDAS on 120 day follow-up 7. Quality of life is measured using EQ-5D-5L questionnaire on Day of discharge and 120 day follow up 8. Ability to perform daily activities is measured using Nottingham Extended Activities of Daily Living (NEADL) on 120 day follow-up 9. Length of hospital stay is measured using medical records on Day of discharge 10. Discharge location is measured using medical records on Day of discharge | — |
Countries
United Kingdom
Contacts
Public ContactJoyce Yeung
Outcome results
None listed