Continuous invasive arterial blood pressure monitoring during orthopaedic trauma surgery Surgery
Conditions
Interventions
Study arms
Participants will be randomly allocated in a 1:1 ratio using block randomisation, stratified by site to either:
Continuous invasive arterial blood pressure monitoring
• Up to three attempts
Sponsors
South Tees Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
65 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. =65 years old 2. Clinically frail – assessed as a Clinical Frailty Scale (CFS) Score of 5 or more 3. Primary proximal hip fracture (fractured neck of femur)
Exclusion criteria
Exclusion criteria: 1. Planned continuous arterial blood pressure monitoring or use of non-invasive blood pressure monitoring at a high frequency 2. Refusal to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. Site setup is measured using number of sites recruiting first participant at end of trial 2. Participant recruitment rate is measured using number of participants recruited per site per month at end of trial 3. Outcome follow-up data completeness is measured using proportion of participant-reported outcome data collected at 120 days 4. Intervention compliance is measured using proportion of participants receiving allocated treatment at end of trial 5. Treatment crossover is measured using proportion of patients not receiving allocated treatment at baseline and during hospital stay 6. Unblinding rate is measured using number of outcome assessors unblinded to trial allocation at 120 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility of data collection of clinical and patient-reported outcome measures: 1. Pre-injury mobility is measured using patient or carer report at baseline 2. Pre-injury quality of life is measured using EuroQol EQ5D5L questionnaire at baseline 3. Pre-injury residential status is measured using patient or carer report at baseline 4. Delirium is measured using 4AT tool at baseline and on day 3 (+/-1 day) post-surgery 5. Comorbidities are measured using patient notes at baseline 6. Drug history is measured using patient notes at baseline 7. Routine blood test results are measured using full blood count, urea and electrolytes, clotting screen, CRP at baseline 8. Blood pressure is measured using standard clinical measurement on admission 9. ASA score is measured using anaesthetic chart at time of surgery 10. Type of anaesthetic is measured using anaesthetic chart at time of surgery 11. Volume of fluids administered is measured using anaesthetic chart during surgery 12. Units of blood products administered is measured using anaesthetic chart during surgery 13. Vasopressor and inotrope use is measured using anaesthetic chart during surgery 14. Estimated blood loss is measured using anaesthetic chart during surgery 15. Cardiac arrest is measured using anaesthetic chart during surgery 16. Death in theatre is measured using anaesthetic chart during surgery 17. Intra-operative blood pressure is measured using uploaded intra-operative measurements during surgery 18. First blood pressure in recovery is measured using standard clinical measurement in recovery room 19. Postoperative complications are measured using Comprehensive Complications Index at 120 days 20. Discharge destination is measured using patient notes at time of hospital discharge 21. Residential status is measured using patient or carer report at 120 days post-surgery 22. Mobility is measured using patient or carer report at 120 days post-surgery 23. Quality of life | — |
Countries
England, United Kingdom
Contacts
Public ContactAndrew Kane
Outcome results
None listed