Blizzard OR Evaluation in femoral neck fracture
Research type
Research Study
Full title
Peri Operative Multilayer Warming Blanket Assessment in femoral neck fracture patients
IRAS ID
240252
Contact name
Simon Burnell
Contact email
Sponsor organisation
Blizzard Protection Systems
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Summary of Research
Femoral neck fracture is a common condition with a high mortality (approximately 7% 30 day mortality). There is literature evidence that temperature of the patient at admission to the Emergency Department is predictive of mortality. Maintenance of patient temperature is subsequently important for patients undergoing surgery. Forced air warming (FAW) blankets have been widely used in orthopaedics to maintain temperature, including in patients undergoing femoral neck fracture surgery. Recent published evidence shows that perioperative hypothermia is startlingly common (30%) in femoral neck fracture patients despite the use of FAW. There are also concerns about airborne contamination of wounds from the FAW devices, with the possibility of increased rates of wound and implant infection. Many patients with femoral neck fractures are placed in a specific position on the fracture table for surgery to permit access for the x-ray image intensifier; this position has been noted to compromise the effectiveness of FAW blankets.\n\nThis study will investigate an alternative (non FAW) warming device. This device has previously been investigated for efficacy in hip and knee replacement patients at Ysbyty Gwynedd, and found to deliver acceptable thermal management and comfort for those patients.\n\nPatients undergoing femoral neck fracture surgery will be randomised to FAW or the novel (Blizzard OR) warming blanket. All surgery will be carried out using standard techniques, including standard anti infection protocols (clean air theatre, occlusive gowns for surgeons, prophylactic antibiotics prior to incision). Patients will take part in the study subject to consent being obtained.\n\nThe major outcome to be studied is maintenance of patient temperature in the operative and immediate postoperative period. Secondary outcome measures include postoperative pain, shivering, blood loss and days till fit to discharge.
Summary of Results
Study terminated after recruitment of 25 patients. This is insufficient for any meaningful analysis of results.
Recruitment was unexpectedly difficulty due to the emergency nature of the cases and was compounded by the manufacturer’s withdrawal of product due to manufacturing difficulties. In discussion with the manufacturer/sponsor we concluded that the study protocol (which relied on the novel product) was now non-viable.REC name
Wales REC 5
REC reference
18/WA/0240
Date of REC Opinion
21 Aug 2018
REC opinion
Further Information Favourable Opinion