Clinical trial · Interventional
Thermal Suit With Forced-air Warming in Breast Cancer Surgery
Thermal Suit With Forced-air Warming in Breast Cancer Surgery: A Randomized Clinical Investigation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypothermia, Accidental | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional hospital clothes | Device | — | UNRESOLVED |
| Thermal suit | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Thermal suit
- interventionNames
- Device: Thermal suit
- type
- ACTIVE_COMPARATOR
- label
- Conventional hospital clothes
- interventionNames
- Device: Conventional hospital clothes
Primary outcomes (1)
- measure
- Core temperature
- timeFrame
- 1 hour
- description
- Core temperature after arriving to the post-anaesthesia care unit
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available