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Thermal Suit With Forced-air Warming in Breast Cancer Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03420924
Enrollment
40
Registered
2018-02-05
Start date
2018-02-20
Completion date
2018-07-06
Last updated
2018-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia, Accidental

Keywords

intraoperative hypothermia, thermal suit, forced-air warming

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.

Interventions

Forced-air warming device will be connected to the trouser legs of the thermal suit.

DEVICEConventional hospital clothes

The warming mattress and a forced-air warming blanket for the lower body will be used intraoperatively.

Sponsors

Tampere University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Core temperature1 hourCore temperature after arriving to the post-anaesthesia care unit

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026