Thermal Suit With Forced-air Warming in Breast Cancer Surgery

Hypothermia, Accidental Clinical Trial

Official title:

Thermal Suit With Forced-air Warming in Breast Cancer Surgery: A Randomized Clinical Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420924
• Other study ID #: R17137
• Status: Completed
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: July 6, 2018

Study information

• Verified date: February 2018
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 6, 2018
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia, Accidental

Intervention

Device:
• Thermal suit
Forced-air warming device will be connected to the trouser legs of the thermal suit.
• Conventional hospital clothes
The warming mattress and a forced-air warming blanket for the lower body will be used intraoperatively.

Locations

Country	Name	City	State
Finland	TAYS Hatanpää	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core temperature	Core temperature after arriving to the post-anaesthesia care unit	1 hour