Back to resultsThermal Suit With Forced-air Warming in Breast Cancer Surgery
Primary Purpose
Hypothermia, Accidental
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Thermal suit
Conventional hospital clothes
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia, Accidental focused on measuring intraoperative hypothermia, thermal suit, forced-air warming
Eligibility Criteria
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
Sites / Locations
- TAYS Hatanpää
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Thermal suit
Conventional hospital clothes
Arm Description
Outcomes
Primary Outcome Measures
Core temperature
Core temperature after arriving to the post-anaesthesia care unit
Secondary Outcome Measures
Full Information
NCT ID
NCT03420924
First Posted
January 29, 2018
Last Updated
October 28, 2018
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03420924
Brief Title
Thermal Suit With Forced-air Warming in Breast Cancer Surgery
Official Title
Thermal Suit With Forced-air Warming in Breast Cancer Surgery: A Randomized Clinical Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
July 6, 2018 (Actual)
Study Completion Date
July 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Accidental
Keywords
intraoperative hypothermia, thermal suit, forced-air warming
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thermal suit
Arm Type
Experimental
Arm Title
Conventional hospital clothes
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Thermal suit
Intervention Description
Forced-air warming device will be connected to the trouser legs of the thermal suit.
Intervention Type
Device
Intervention Name(s)
Conventional hospital clothes
Intervention Description
The warming mattress and a forced-air warming blanket for the lower body will be used intraoperatively.
Primary Outcome Measure Information:
Title
Core temperature
Description
Core temperature after arriving to the post-anaesthesia care unit
Time Frame
1 hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maija-Liisa Kalliomäki
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
TAYS Hatanpää
City
Tampere
ZIP/Postal Code
33900
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Thermal Suit With Forced-air Warming in Breast Cancer Surgery
We'll reach out to this number within 24 hrs