SurgeryNCT02336152
Use of Onepiece Suit or Forced Warm Air for Perioperative Temperature Conservation.
A study testing Anaesthesia, Teles Pro, Body suit in people with Surgery, run by Oslo University Hospital at 1 site in Norway.
Trial summary
To study if a one piece body suite (T-balance, Telespro, Finland) is equally effective in maintaining peri-operative body temperature as forced air warming, during open low-back surgery of medium duration. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery
- What is being tested?
- Anaesthesia, Teles Pro, Body suit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2015to Jul 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-3
- Approved consent
- Expected duration of open back surgery of 60-120 min
- Prestudy core temperature (oral) of at least 36 degrees C
Who cannot join
- Known diabetes mellitus
- Any known illness or use of pre-op drugs which may interfere with normal temperature regulation
- Body mass index less than 17 or more than 35
- Pregnancy
- Any contraindication for warming device or temperature monitor
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Oslo, 0407
About this study
To study if a one piece body suite (T-balance, Telespro, Finland) is equally effective in maintaining peri-operative body temperature as forced air warming, during open low-back surgery of medium duration.
- Conditions
- Surgery
- Being tested
- Anaesthesia, Teles Pro, Body suit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anaesthesia, Teles Pro, Body suitDevice
| Study group | Role | What they receive |
|---|---|---|
| Body suit | Experimental | The patients will receive a body suit at least 30 min before start of general anaesthesia, and will keep the suit on until warm and comfortable in the post-operative unit. The suit is supplied with multiple snap openings to allow for draping, washing and surgery. Receives: Device: Anaesthesia, Teles Pro, Body suit |
| Forced warm air | Active comparator | The patients will receive forced warm air on their lower body when placed on operating table, ready for surgery. Receives: Device: Anaesthesia, Teles Pro, Body suit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body core temperature
SpotOn (3M) measurement in the forehead
Measured: 30 minutes after anaesthesia induction
Secondary outcomes (2)
Body core temperature
Measured: 1 hr before - intraoperative - 3 hrs postoperative
Patient termal satisfaction
patient interview
Measured: 1 hr before - intraoperative - 3 hrs postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Oslo 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336152
- Sponsor's protocol ID
- Varmedrakt.OUS.15.1
- Status last verified
- Jan 2015
- First submitted
- 5 Jan 2015
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Onepiece Suit or Forced Warm Air for Perioperative Temperature Conservation.
- ClinicalTrials.gov ID
- NCT02336152
- Acronym / sponsor ID
- Varmedrakt.OUS.15.1
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 12 Jan 2015 (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.
To study if a one piece body suite (T-balance, Telespro, Finland) is equally effective in maintaining peri-operative body temperature as forced air warming, during open low-back surgery of medium duration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body suit | Experimental | Device: Anaesthesia, Teles Pro, Body suitThe patients will receive a body suit at least 30 min before start of general anaesthesia, and will keep the suit on until warm and comfortable in the post-operative unit. The suit is supplied with multiple snap openings to allow for draping, washing and surgery. |
| Forced warm air | Active comparator | Device: Anaesthesia, Teles Pro, Body suitThe patients will receive forced warm air on their lower body when placed on operating table, ready for surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA 1-3
- Approved consent
- Expected duration of open back surgery of 60-120 min
- Prestudy core temperature (oral) of at least 36 degrees C
Key exclusion criteria (5 listed)
- Known diabetes mellitus
- Any known illness or use of pre-op drugs which may interfere with normal temperature regulation
- Body mass index less than 17 or more than 35
- Pregnancy
- Any contraindication for warming device or temperature monitor
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 |
|---|---|---|
| Anaesthesia, Teles Pro, Body suit | Device | Body suit, Forced warm air |
Primary outcome
Body core temperature
Time frame: 30 minutes after anaesthesia induction
SpotOn (3M) measurement in the forehead
2 secondary outcomes
Body core temperature
Time frame: 1 hr before - intraoperative - 3 hrs postoperative
Patient termal satisfaction
Time frame: 1 hr before - intraoperative - 3 hrs postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anaesthesia, Teles Pro, Body suit in people with Surgery, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Jan 2015. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Raeder, PhD (004792249669, johan.rader@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body core temperature (time frame: 30 minutes after anaesthesia induction). 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 12 Jan 2015.