Prostate CancerPhase 4NCT01571544
The Use of Thermal Suits as Preventing Hypothermia During Surgery
A Phase 4 study testing Thermal suit and Conventional clothing in people with Prostate Cancer, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Unintentional hypothermia of a patient is a common adverse effect during surgical procedures. The aim of this prospective, randomised, controlled study is to determine whether the use of thermal suit could prevent surgical patient from experiencing thermal loss than conventional measures. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Thermal suit and Conventional clothing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2012to Nov 2014
- Phase
- Phase 4
- 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 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- radical prostatectomy, American Society of Anaesthesiologists class I-III, age 18-90
Who cannot join
- mental status with inability to give informed consent, neuromuscular disorders, Raynaud's disease, unstable angina pectoris
Trial locations and contacts
1 site in 1 country.
About this study
Unintentional hypothermia of a patient is a common adverse effect during surgical procedures. The aim of this prospective, randomised, controlled study is to determine whether the use of thermal suit could prevent surgical patient from experiencing thermal loss than conventional measures.
Hypothesis: The investigators assume that a difference of 0.5°C in body temperature between the groups is clinically relevant.
Read the detailed description
The aim of this study was to compare a thermal suit (T-Balance) and conventional warming methods to maintain a constant body temperature in patients undergoing robotic laparoscopic radical prostatectomy under general anesthesia.
A sample size calculation was made using a power analysis. Patients were randomly allocated into two groups.
Patients in the intervention group were put on the T-Balance 1 hour before anesthesia induction. Patients in the control group got conventional cotton clothes. Intra-operatively same warming methods were used in both groups. The measuring points of the temperature were esophagus (core temperature), left axilla, dorsal surface of the left middle finger and back of the left foot.
Anesthesia was induced via target-controlled infusion. All temperature data of the patients were collected and recorded electrically and continuously.
- Conditions
- Prostate Cancer
- Being tested
- Thermal suit, Conventional clothing
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal suitDevice
Thermal suit
Conventional clothingOther
Conventional clothing
| Study group | Role | What they receive |
|---|---|---|
| Thermal suit | Experimental | Randomly selected half of the patients will use thermal suit prior to anesthesia, during the surgery and post anesthesia care unit. Receives: Device: Thermal suit |
| Conventional clothing | Active comparator | Randomly selected half of the patients will use conventional clothing prior to anesthesia, during the surgery and post anesthesia care unit. Receives: Other: Conventional clothing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Measured: from one hour before surgery up to the ward after surgery, estimated 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sirkka-Liisa Lauronen, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571544
- Sponsor's protocol ID
- R12038
- Status last verified
- Jan 2017
- First submitted
- 29 Mar 2012
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Thermal Suits as Preventing Hypothermia During Surgery
- ClinicalTrials.gov ID
- NCT01571544
- Acronym / sponsor ID
- R12038
- Conditions
- Prostate Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 Apr 2012 (estimated)
- 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.
Unintentional hypothermia of a patient is a common adverse effect during surgical procedures. The aim of this prospective, randomised, controlled study is to determine whether the use of thermal suit could prevent surgical patient from experiencing thermal loss than conventional measures.
Hypothesis: The investigators assume that a difference of 0.5°C in body temperature between the groups is clinically relevant.
Detailed description
The aim of this study was to compare a thermal suit (T-Balance) and conventional warming methods to maintain a constant body temperature in patients undergoing robotic laparoscopic radical prostatectomy under general anesthesia.
A sample size calculation was made using a power analysis. Patients were randomly allocated into two groups.
Patients in the intervention group were put on the T-Balance 1 hour before anesthesia induction. Patients in the control group got conventional cotton clothes. Intra-operatively same warming methods were used in both groups. The measuring points of the temperature were esophagus (core temperature), left axilla, dorsal surface of the left middle finger and back of the left foot.
Anesthesia was induced via target-controlled infusion. All temperature data of the patients were collected and recorded electrically and continuously.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermal suit | Experimental | Device: Thermal suitRandomly selected half of the patients will use thermal suit prior to anesthesia, during the surgery and post anesthesia care unit. |
| Conventional clothing | Active comparator | Other: Conventional clothingRandomly selected half of the patients will use conventional clothing prior to anesthesia, during the surgery and post anesthesia care unit. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- radical prostatectomy, American Society of Anaesthesiologists class I-III, age 18-90
Key exclusion criteria (1 listed)
- mental status with inability to give informed consent, neuromuscular disorders, Raynaud's disease, unstable angina pectoris
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 suitThermal suit | Device | Thermal suit |
| Conventional clothingConventional clothing | Other | Conventional clothing |
Primary outcome
Temperature
Time frame: from one hour before surgery up to the ward after surgery, estimated 10 hours
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 4 Jan 2017.
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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.
Sirkka-Liisa Lauronen, MD principal investigator
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 Phase 4 study testing Thermal suit and Conventional clothing in people with Prostate Cancer, 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 1 inclusion and 1 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 4 Jan 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Temperature (time frame: from one hour before surgery up to the ward after surgery, estimated 10 hours). 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 4 Jan 2017.