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Completed

NCT Number: NCT03420924

Thermal Suit With Forced-air Warming in Breast Cancer Surgery

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.

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Key information

Conditions

Hypothermia, Accidental Body Temperature Changes Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

TAYS Hatanpää

Tampere, 33900, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermal suit

Device

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

Conventional hospital clothes

Device

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

Primary outcomes

  1. Core temperature

    Time frame: 1 hour

    Core temperature after arriving to the post-anaesthesia care unit

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2018
Registry last updated
Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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