HypothermiaNCT02467777
Comparison of Forced Air and Conductive Patient Heating Systems During Ambulatory Surgeries
A study testing Bair Hugger and VitaHeat in people with Hypothermia, run by Fox Valley Orthopedic Institute at 1 site in United States.
Trial summary
Comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothermia
- What is being tested?
- Bair Hugger and VitaHeat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing orthopaedic outpatient surgeries over 18 years old
Who cannot join
- allergic to material of bair hugger
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries.
Read the detailed description
Patients will be randomized into either the Forced Air group (FA) or Conductive Heat group (CH). Randomization will be based on computer-generated codes that will be maintained in sequentially numbered opaque envelopes. Fifty patients will be recruited with 25 patients being randomized into each group.
In patients assigned to the FA group, a Bair Hugger (Arizant Medical, Inc., Eden Prairie, Minnesota) forced-air cover will be positioned over the upper body (if lower extremity surgery) or lower body (if upper extremity surgery). The forced-air blower will be set and activated per standard practice usually after prepping and draping.
In patients assigned to the CH group, a VitaHeat (VitaHeat, Inc, Aurora, IL) conductive heating device will be placed under the torso of the patient. The device will be set and activated per standard practice usually just after positioning of the patient on the operating table.
Patients in both groups will be otherwise draped per surgical routine. Ambient temperature will be maintained near 20°C. Temperatures will be recorded using a temporal artery thermometer.
- Conditions
- Hypothermia
- Being tested
- Bair Hugger, VitaHeat
- Keywords
- orthopaedics, post-operative warming
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bair HuggerDevice
VitaHeatDevice
| Study group | Role | What they receive |
|---|---|---|
| Forced Air | Active comparator | Bair Hugger Receives: Device: Bair Hugger |
| Conductive Warming | Active comparator | VitaHeat Receives: Device: VitaHeat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Measured by temporal artery thermometer
Measured: Intra-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Valley Orthopedic Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vishal Mehta, Fox Valley Orthopedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467777
- Sponsor's protocol ID
- 15-025
- Status last verified
- Apr 2017
- First submitted
- 23 Apr 2015
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Forced Air and Conductive Patient Heating Systems During Ambulatory Surgeries
- ClinicalTrials.gov ID
- NCT02467777
- Acronym / sponsor ID
- 15-025
- Conditions
- Hypothermia
- Keywords
- orthopaedics, post-operative warming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fox Valley Orthopedic InstituteUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Posted 23 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries.
Detailed description
Patients will be randomized into either the Forced Air group (FA) or Conductive Heat group (CH). Randomization will be based on computer-generated codes that will be maintained in sequentially numbered opaque envelopes. Fifty patients will be recruited with 25 patients being randomized into each group.
In patients assigned to the FA group, a Bair Hugger (Arizant Medical, Inc., Eden Prairie, Minnesota) forced-air cover will be positioned over the upper body (if lower extremity surgery) or lower body (if upper extremity surgery). The forced-air blower will be set and activated per standard practice usually after prepping and draping.
In patients assigned to the CH group, a VitaHeat (VitaHeat, Inc, Aurora, IL) conductive heating device will be placed under the torso of the patient. The device will be set and activated per standard practice usually just after positioning of the patient on the operating table.
Patients in both groups will be otherwise draped per surgical routine. Ambient temperature will be maintained near 20°C. Temperatures will be recorded using a temporal artery thermometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forced Air | Active comparator | Device: Bair HuggerBair Hugger |
| Conductive Warming | Active comparator | Device: VitaHeatVitaHeat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing orthopaedic outpatient surgeries over 18 years old
Key exclusion criteria (1 listed)
- allergic to material of bair hugger
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 |
|---|---|---|
| Bair Hugger | Device | Forced Air |
| VitaHeat | Device | Conductive Warming |
Primary outcome
Temperature
Time frame: Intra-Operative
Measured by temporal artery thermometer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bair Hugger and VitaHeat in people with Hypothermia, run by Fox Valley Orthopedic Institute at 1 site in United States.
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 11 May 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Intra-Operative). 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 11 May 2017.