HypothermiaPhase 3HDVNCT00772460
Comparison of a New Patient Warming System Using Polymer Conductive Warming With Forced Air Warming During Surgery
A Phase 3 study testing Patient Warming with conductive / convective warming in people with Hypothermia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Two patient warming systems will be compared with 40 patients each in a convective warming group (BairHugger, Arizant) and in a conductive warming group (HotDog, Augustine Biomedical). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypothermia
- What is being tested?
- Patient Warming with conductive / convective warming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2008to Jun 2009
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients must have normal weight (20-30 BMI), the duration of surgery should last between 3 - 4 hours.
- There will be no other exclusion criteria , as forced air patient warming is routinely used for all patients during this procedure.
Who cannot join
- Severe peripheral artery disease in the warmed extremity
Trial locations and contacts
1 site in 1 country.
About this study
Two patient warming systems will be compared with 40 patients each in a convective warming group (BairHugger, Arizant) and in a conductive warming group (HotDog, Augustine Biomedical).
The patients will undergo small to medium trauma surgery and will be warmed with the randomized device - the hypothesis is, that the area under the standardized core temperature / time curve is significantly greater in the conductive warming group. Secondary outcome is the mean skin temperature / time area under the curve.
Read the detailed description
General study design We will study 200 patients (18-90 years) undergoing elective orthopedic surgery at the trauma surgery unit. The patients must have normal weight (20-30 BMI), the duration of surgery should last between 3 - 4 hours. There will be no other exclusion criteria (except severe peripheral arterial disease in the warmed extremity), as forced air patient warming is routinely used for all patients during this procedure.
The patients will be randomly assigned via a computer generated randomization list to treatment with either polymer or forced air warming. Anaesthesia and fluid management will be administered as desired by the anaesthesiologist.
Before warming four skin temperature probes will be attached to the upper arm, chest, abdomen and back of the patients to calculate mean body temperature. A probe (Mallinckrodt Anesthesiology Products, Inc., St. Louis, MO) will be introduced in the ear to measure core temperature. Afterwards, treatment with BairHugger or HotDog will be started.
The measurements will be recorded every five minutes until the end of surgery when intraoperative warming is stopped.
Differences between core temperatures will be analyzed both by using the summary measure of AUC (area under the curve) and by comparing the core-temperature at the end of surgery in the polymer and the forced air group with two-tailed, unpaired t tests if normally distributed and with a Wilcoxon test, if not normally distributed (distribution tested by K-S-test).
Results are expressed as means ± standard deviations if normally distributed, as median (IQ-Range) when not normally distributed.
Differences will be considered statistically significant when P < 0.05. We consider a difference in core temperature at the end of surgery of 0.5°C as clinically important. Considering this difference as well as a known standard deviation of approximately 1.5°C we will have to study 40 patients in each arm of the study to achieve statistical significance using a power of 90% and a p-value of 0.05.
- Conditions
- Hypothermia
- Being tested
- Patient Warming with conductive / convective warming
- Keywords
- patient warming, convective warming, conductive warming, intraoperative normothermia, accidental hypothermia, intraoperative hypothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Warming with conductive / convective warmingDevice
Warming device set to maximum (43 °C)
| Study group | Role | What they receive |
|---|---|---|
| Forced Air | Active comparator | Warming with forced air (BairHugger) Receives: Device: Patient Warming with conductive / convective warming |
| Conductive Warming | Experimental | Warming with the conductive device (HotDog) Receives: Device: Patient Warming with conductive / convective warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the standardized "core temperature * time" curve
Measured: intraoperatively
Secondary outcomes (1)
Area under "mean skin temperature * time" curve
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Oliver Kimberger, M.D., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772460
- Sponsor's protocol ID
- HotDogVienna
- Acronym
- HDV
- Status last verified
- Sep 2009
- First submitted
- 14 Oct 2008
- Last updated
- 21 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Brandt S, Oguz R, Huttner H, Waglechner G, Chiari A, Greif R, Kurz A, Kimberger O. Resistive-polymer versus forced-air warming: comparable efficacy in orthopedic patients. Anesth Analg. 2010 Mar 1;110(3):834-8. doi: 10.1213/ANE.0b013e3181cb3f5f. Epub 2009 Dec 30.
PubMed 20042442
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a New Patient Warming System Using Polymer Conductive Warming With Forced Air Warming During Surgery
- ClinicalTrials.gov ID
- NCT00772460
- Acronym / sponsor ID
- HDV / HotDogVienna
- Conditions
- Hypothermia
- Keywords
- patient warming, convective warming, conductive warming, intraoperative normothermia, accidental hypothermia, intraoperative hypothermia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Oct 2008 (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.
Two patient warming systems will be compared with 40 patients each in a convective warming group (BairHugger, Arizant) and in a conductive warming group (HotDog, Augustine Biomedical).
The patients will undergo small to medium trauma surgery and will be warmed with the randomized device - the hypothesis is, that the area under the standardized core temperature / time curve is significantly greater in the conductive warming group. Secondary outcome is the mean skin temperature / time area under the curve.
Detailed description
General study design We will study 200 patients (18-90 years) undergoing elective orthopedic surgery at the trauma surgery unit. The patients must have normal weight (20-30 BMI), the duration of surgery should last between 3 - 4 hours. There will be no other exclusion criteria (except severe peripheral arterial disease in the warmed extremity), as forced air patient warming is routinely used for all patients during this procedure.
The patients will be randomly assigned via a computer generated randomization list to treatment with either polymer or forced air warming. Anaesthesia and fluid management will be administered as desired by the anaesthesiologist.
Before warming four skin temperature probes will be attached to the upper arm, chest, abdomen and back of the patients to calculate mean body temperature. A probe (Mallinckrodt Anesthesiology Products, Inc., St. Louis, MO) will be introduced in the ear to measure core temperature. Afterwards, treatment with BairHugger or HotDog will be started.
The measurements will be recorded every five minutes until the end of surgery when intraoperative warming is stopped.
Differences between core temperatures will be analyzed both by using the summary measure of AUC (area under the curve) and by comparing the core-temperature at the end of surgery in the polymer and the forced air group with two-tailed, unpaired t tests if normally distributed and with a Wilcoxon test, if not normally distributed (distribution tested by K-S-test).
Results are expressed as means ± standard deviations if normally distributed, as median (IQ-Range) when not normally distributed.
Differences will be considered statistically significant when P < 0.05. We consider a difference in core temperature at the end of surgery of 0.5°C as clinically important. Considering this difference as well as a known standard deviation of approximately 1.5°C we will have to study 40 patients in each arm of the study to achieve statistical significance using a power of 90% and a p-value of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forced Air | Active comparator | Device: Patient Warming with conductive / convective warmingWarming with forced air (BairHugger) |
| Conductive Warming | Experimental | Device: Patient Warming with conductive / convective warmingWarming with the conductive device (HotDog) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patients must have normal weight (20-30 BMI), the duration of surgery should last between 3 - 4 hours.
- There will be no other exclusion criteria , as forced air patient warming is routinely used for all patients during this procedure.
Key exclusion criteria (1 listed)
- Severe peripheral artery disease in the warmed extremity
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 |
|---|---|---|
| Patient Warming with conductive / convective warmingWarming device set to maximum (43 °C) | Device | Conductive Warming, Forced Air |
Primary outcome
Area under the standardized "core temperature * time" curve
Time frame: intraoperatively
1 secondary outcome
Area under "mean skin temperature * time" curve
Time frame: intraoperatively
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 21 Sep 2009.
- Derived from this study: PubMed 20042442Brandt S, Oguz R, Huttner H, Waglechner G, Chiari A, Greif R, Kurz A, Kimberger O. Resistive-polymer versus forced-air warming: comparable efficacy in orthopedic patients. Anesth Analg. 2010 Mar 1;110(3):834-8. doi: 10.1213/ANE.0b013e3181cb3f5f. Epub 2009 Dec 30.
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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.
Oliver Kimberger, M.D. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Patient Warming with conductive / convective warming in people with Hypothermia, run by Medical University of Vienna at 1 site in Austria.
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 2 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 21 Sep 2009. 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 Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Area under the standardized "core temperature * time" curve (time frame: intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00772460, which also lists 1 linked publication.
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 21 Sep 2009.