Hypothermia, AccidentalNCT03420924
Thermal Suit With Forced-air Warming in Breast Cancer Surgery
A study testing Thermal suit and Conventional hospital clothes in people with Hypothermia, Accidental, run by Tampere University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years, women only
- Conditions the study is for
- Hypothermia, Accidental
- What is being tested?
- Thermal suit and Conventional hospital clothes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 20 Feb 2018to 6 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary breast cancer surgery
- unilateral resection or mastectomy with or without axillar lymphadenectomy
- body mass index 25-40
Who cannot join
- ASA > III
- decreased mental status
- inadequate Finnish language skills
- other than general anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hypothermia, Accidental
- Being tested
- Thermal suit, Conventional hospital clothes
- Keywords
- intraoperative hypothermia, thermal suit, forced-air warming
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal suitDevice
Forced-air warming device will be connected to the trouser legs of the thermal suit.
Conventional hospital clothesDevice
The warming mattress and a forced-air warming blanket for the lower body will be used intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Thermal suit | Experimental | Not described Receives: Device: Thermal suit |
| Conventional hospital clothes | Active comparator | Not described Receives: Device: Conventional hospital clothes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature
Core temperature after arriving to the post-anaesthesia care unit
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start20 Feb 2018
- Primary completion6 Jul 2018
- Study completion6 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia, AccidentalStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maija-Liisa Kalliomäki, Study director, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420924
- Sponsor's protocol ID
- R17137
- Status last verified
- Feb 2018
- First submitted
- 29 Jan 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Suit With Forced-air Warming in Breast Cancer Surgery: A Randomized Clinical Investigation
- ClinicalTrials.gov ID
- NCT03420924
- Acronym / sponsor ID
- R17137
- Conditions
- Hypothermia, Accidental
- Keywords
- intraoperative hypothermia, thermal suit, forced-air warming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermal suit | Experimental | Device: Thermal suit |
| Conventional hospital clothes | Active comparator | Device: Conventional hospital clothes |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary breast cancer surgery
- unilateral resection or mastectomy with or without axillar lymphadenectomy
- body mass index 25-40
Key exclusion criteria (4 listed)
- ASA > III
- decreased mental status
- inadequate Finnish language skills
- other than general anaesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal suitForced-air warming device will be connected to the trouser legs of the thermal suit. | Device | Thermal suit |
| Conventional hospital clothesThe warming mattress and a forced-air warming blanket for the lower body will be used intraoperatively. | Device | Conventional hospital clothes |
Primary outcome
Core temperature
Time frame: 1 hour
Core temperature after arriving to the post-anaesthesia care unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maija-Liisa Kalliomäki study director
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal suit and Conventional hospital clothes in people with Hypothermia, Accidental, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core temperature (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.