Patients & healthcare professionals views on tourniquet use in surgery
Research type
Research Study
Full title
Exploration of Patients Views on Recovery Outcomes and Healthcare Professionals Views on Trial Design of Tourniquet Use in Ankle Fracture Surgery
IRAS ID
323696
Contact name
Julie Bruce
Contact email
Sponsor organisation
University of Warwick
Clinicaltrials.gov Identifier
MF630323, Trial Management Reference Number
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Tourniquets are commonly used during ankle fracture fixation surgery. This is a device which is applied around the thigh and stops blood flowing through the leg during the operation. Some surgeons believe it helps reduce intra-operative blood loss and improves their field of view, reducing operative time. However, tourniquets have been associated with various adverse effects such as increased pain, and risk of blood clot formation inside the deep veins of the leg (which can occasionally break off and travel to the lungs). Tourniquets also reduce the amount of oxygen being delivered to the soft tissues which might increase the risk of wound healing complications. Considering the clinical uncertainty regarding tourniquet use, a well-designed, multicentre trial addressing the flaws and limitations of previous studies is required to inform clinical practice.
This study aims to inform the design of a future trial investigating tourniquet use in ankle fracture fixation surgery through involvement of key stakeholders (patients, surgeons, and anaesthetists). Participants will be recruited from the University Hospital Coventry & Warwickshire and Royal London Hospital. It consists of two parts:
A) Focus group meetings will take place with patients who have undergone ankle fracture fixation surgery. We will explore patients’ views on recovering from ankle fracture fixation surgery, what outcomes matter most to them and their knowledge about tourniquet use. The focus group sessions will be recorded, transcribed verbatim and anonymised.
B) a virtual nominal group technique consensus meeting will take place with Orthopaedic Trauma surgeons and anaesthetists. The results will help refine three key design considerations: participant eligibility criteria, techniques for blinding patients and the surgical team, as well as refining parameters of the intervention and control arms.
This two-staged approach will help ensure the results of the future trial are informative to clinical practice from the perspectives of stakeholders.
REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0214
Date of REC Opinion
22 Sep 2023
REC opinion
Favourable Opinion