Thermal Suit With Forced-air Warming in Breast Cancer Surgery

Tampere University Hospital

Status: Completed

Conditions: Hypothermia, Accidental

Treatments: Device: Thermal suit; Device: Conventional hospital clothes

Study type: Interventional

Funder types: Other

Identifiers

NCT03420924

R17137

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary breast cancer surgery
• unilateral resection or mastectomy with or without axillar lymphadenectomy
• body mass index 25-40

Exclusion criteria

• ASA > III
• decreased mental status
• inadequate Finnish language skills
• other than general anaesthesia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Thermal suit

Experimental group

Treatment:

Device: Thermal suit

Conventional hospital clothes

Active Comparator group

Treatment:

Device: Conventional hospital clothes