Thermal Suit With Forced-air Warming in Breast Cancer Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Hypothermia, Accidental
• Intervention / Treatment: Device: Thermal suit; Device: Conventional hospital clothes

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33900
    • TAYS Hatanpää

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core temperature	Core temperature after arriving to the post-anaesthesia care unit	1 hour

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2018
• Primary Completion (ACTUAL): July 6, 2018
• Study Completion (ACTUAL): July 6, 2018

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (ACTUAL): February 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: forced-air warming; intraoperative hypothermia; thermal suit
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: R17137

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No