Does continuous arterial blood pressure monitoring during surgery benefit patients who are high risk, particularly those who are older and living with frailty?
| ISRCTN | ISRCTN12558538 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12558538 |
| IRAS number | 351284 |
| Secondary identifying numbers | R&D 24/006 |
- Submission date
- 10/07/2025
- Registration date
- 09/09/2025
- Last edited
- 09/09/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Many people have low blood pressure during surgery, which can be harmful, especially for older or frail patients. This can affect important organs like the heart, kidneys, or brain. One way to help is by measuring blood pressure continuously during surgery using a drip in the wrist, instead of checking it every few minutes with a cuff. This might help doctors spot and treat low blood pressure more quickly. However, this method isn’t used often because there isn’t enough research to support it. This study aims to find out if continuous blood pressure monitoring during surgery helps high-risk patients, especially those having surgery for a broken hip.
Who can participate?
The study is for people aged 65 or older who are considered frail and need surgery for a broken hip.
What does the study involve?
Participants will be randomly placed into one of two groups. One group will have their blood pressure measured continuously during surgery using a drip in the wrist. The other group will have it measured at regular intervals using a cuff. Researchers will look at how well the study works, track blood pressure during surgery, check for any complications, and ask patients about their quality of life afterward.
What are the possible benefits and risks of participating?
The study may help improve care for future patients by showing whether continuous blood pressure monitoring is better. There may be some small risks from the drip used for monitoring, such as discomfort or infection, but these are rare and will be carefully managed.
Where is the study run from?
South Tees Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
The study started in June 2025 and is expected to run until April 2028.
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Andrew Kane, andrew.kane@nhs.net
Contact information
Public, Scientific, Principal Investigator
South Tees Hospitals NHS Foundation Trust
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
 ORCID ID |
0000-0001-9488-4086 |
|---|---|
| Phone | +44 7709619017 |
| andrew.kane@nhs.net |
Study information
| Study design | A feasibility study consisting of an external multi-centre two-arm parallel-group assessor-blinded randomized pilot trial with a nested qualitative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention, Safety |
| Participant information sheet | To follow |
| Scientific title | Continuous ARterial monitoring in Elderly and Frail patients for hip fractUre surgery to prevent Low blood pressure |
| Study acronym | CAREFUL |
| Study objectives | 1. To undertake a systematic review and meta-analysis to understand what is currently known regarding the use of continuous blood pressure monitoring and its impact on intra-operative hypotension and associated morbidity. 2. To understand clinician attitudes towards continuous arterial monitoring in older frail patients presenting for trauma surgery through questionnaires and focus groups. 3. To undertake a feasibility study with embedded qualitative research to assess whether a full-scale randomised controlled trial (RCT) of continuous invasive arterial blood pressure monitoring versus standard care is feasible in the older, frail patient population presenting for hip fracture surgery. |
| Ethics approval(s) |
Not yet submitted, Ethics committee name not provided (Address not provided, City not provided, Zip/postal code not provided; Telephone number not provided; Email not provided), ref: 25/WA/0235 |
| Health condition(s) or problem(s) studied | Continuous invasive arterial blood pressure monitoring during orthopaedic trauma surgery |
| Intervention | 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 to establish continuous invasive arterial blood pressure monitoring using local anaesthesia before general or neuraxial anaesthesia. • Continuous arterial blood pressure monitoring will be maintained until the patient reaches the recovery room, where it may be discontinued or continued at the discretion of the clinical team. OR Standard care • 3-to-5-minute cycles of blood pressure monitoring. Duration of treatment Start: From the start of anaesthesia care. End: The randomised treatment can be removed at a point the clinician feels is appropriate- normally in the recovery room. Follow-up period 120 days from the day of surgery. Randomisation The randomisation schedule will be stratified by site and formed of randomly permuted blocks of randomly varying size using a 1:1 allocation ratio. The allocation sequence will be generated by a statistician not involved in the study and uploaded to the REDCap platform. Following consent, randomisation will be performed immediately via the REDCap platform. Clinical teams will be informed as early as possible to allow planning of care. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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 is measured using EuroQol EQ5D5L questionnaire at 120 days (+/-7 days) post-surgery |
| Overall study start date | 01/06/2025 |
| Completion date | 01/04/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/10/2025 |
| Date of final enrolment | 01/10/2027 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Department
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
England
United Kingdom
| Phone | +44 1642 850850 Ext 54222 |
|---|---|
| stees.tvra.projects@nhs.net | |
| Website | http://southtees.nhs.uk/ |
"ROR" |
https://ror.org/02js17r36 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. We will also hold a stakeholder event, including PPI representation, to disseminate findings, gather feedback and guide the development of a definitive study. We will communicate the results to the Centre for Peri-operative Care to inform future iterations of peri-operative guidelines for patients living with frailty. Findings will be presented at conferences and meetings (including RCoA and RCS events where team members regularly present), and feedback will be given to the PPI group. All WP will be published in peer-reviewed journals with open access. The aim will be to build engagement with clinicians who may become PIs. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Editorial Notes
24/07/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
