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Thermal Suit With Forced-air Warming in Breast Cancer Surgery

Sponsor
Tampere University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03420924
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
4.5
Actual Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Thermal suit
  • Device: Conventional hospital clothes
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Thermal Suit With Forced-air Warming in Breast Cancer Surgery: A Randomized Clinical Investigation
Actual Study Start Date :
Feb 20, 2018
Actual Primary Completion Date :
Jul 6, 2018
Actual Study Completion Date :
Jul 6, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Thermal suit

Device: Thermal suit
Forced-air warming device will be connected to the trouser legs of the thermal suit.
Active Comparator: Conventional hospital clothes

Device: Conventional hospital clothes
The warming mattress and a forced-air warming blanket for the lower body will be used intraoperatively.

Outcome Measures

Primary Outcome Measures

  1. Core temperature [1 hour]

    Core temperature after arriving to the post-anaesthesia care unit

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 90 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 TAYS Hatanpää Tampere Finland 33900

Sponsors and Collaborators

  • Tampere University Hospital

Investigators

  • Study Director: Maija-Liisa Kalliomäki, Tampere University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT03420924
Other Study ID Numbers:
  • R17137
First Posted:
Feb 5, 2018
Last Update Posted:
Oct 30, 2018
Last Verified:
Feb 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tampere University Hospital
intraoperative hypothermia
thermal suit
forced-air warming
Additional relevant MeSH terms:
Hypothermia

Study Results

No Results Posted as of Oct 30, 2018