Thermal Suit With Forced-air Warming in Breast Cancer Surgery

NCT ID: NCT03420924

Last Updated: 2018-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-20

Study Completion Date

2018-07-06

Brief Summary

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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.

Detailed Description

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Conditions

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Hypothermia, Accidental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Thermal suit

Group Type EXPERIMENTAL

Thermal suit

Intervention Type DEVICE

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

Conventional hospital clothes

Group Type ACTIVE_COMPARATOR

Conventional hospital clothes

Intervention Type DEVICE

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

Interventions

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Thermal suit

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

Intervention Type DEVICE

Conventional hospital clothes

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maija-Liisa Kalliomäki

Role: STUDY_DIRECTOR

Tampere University Hospital

Locations

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TAYS Hatanpää

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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R17137

Identifier Type: -

Identifier Source: org_study_id

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