Thermal Suit With Forced-air Warming in Breast Cancer Surgery
- Conditions
- Hypothermia, Accidental
- Interventions
- Device: Conventional hospital clothesDevice: Thermal suit
- Registration Number
- NCT03420924
- Lead Sponsor
- Tampere University Hospital
- Brief Summary
The aim of this clinical investigation is to prove that the thermal suit with forced-air warming is more effective to prevent inadvertent intraoperative hypothermia than conventional warming methods. The study group will have the thermal suit from arriving to the hospital until to the ward after surgery. In the operating theatre forced-air warming device will be connected to the trouser legs of the thermal suit and the device will be turned on during surgery. The control group will have normal hospital clothes. Intraoperative warming will be managed with the warming mattress and a forced-air warming blanket. The primary endpoint is core temperature after arriving to the post-anaesthesia care unit.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- primary breast cancer surgery
- unilateral resection or mastectomy with or without axillar lymphadenectomy
- body mass index 25-40
- ASA > III
- decreased mental status
- inadequate Finnish language skills
- other than general anaesthesia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional hospital clothes Conventional hospital clothes - Thermal suit Thermal suit -
- Primary Outcome Measures
Name Time Method Core temperature 1 hour Core temperature after arriving to the post-anaesthesia care unit
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
TAYS Hatanpää
🇫🇮Tampere, Finland