Orthopedic SurgeryNCT00670826
Comparison Study of Intraoperative Patient Warming Systems
A study testing vitalHEAT vH2 Temperature Management System and Arizant Healthcare Bair Hugger Temperature Management System in people with Orthopedic Surgery and General Anesthesia, run by Dynatherm Medical Inc. at 1 site in United States.
Trial summary
Medications used to put people to sleep during surgical procedures also cause changes in the body's ability to control its temperature. These changes can make a person's temperature drop below normal. To minimize this drop in body temperature, different types of body warming products are used during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Surgery, General Anesthesia
- What is being tested?
- vitalHEAT vH2 Temperature Management System and Arizant Healthcare Bair Hugger Temperature Management System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Nov 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pts undergoing orthopedic surgical procedure with expected duration 2-3 hrs
- General anesthesia required
- ASA physical status I-III
Who cannot join
- General anesthesia plus epidural anesthesia required
- Skin abrasions/trauma to extremity selected as application site
- History of peripheral vascular disease
- History of malignant hyperthermia
- Unwilling/unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHEAT Temperature Management System(vH2)With the Arizant Bair Hugger System
Medications used to put people to sleep during surgical procedures also cause changes in the body's ability to control its temperature. These changes can make a person's temperature drop below normal. To minimize this drop in body temperature, different types of body warming products are used during surgery. This study is designed to compare the the temperatures of people under general anesthesia after 60 minutes of warming with each product. The study hypothesis is that the people warmed with the Dynatherm Medical vitalHEAT vH2 System will decrease less in the first 60 minutes of warming time than people warmed with the Arizant Bair Hugger System.
- Conditions
- Orthopedic Surgery, General Anesthesia
- Being tested
- vitalHEAT vH2 Temperature Management System, Arizant Healthcare Bair Hugger Temperature Management System
- Keywords
- Patient warming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitalHEAT vH2 Temperature Management SystemDevice
The vH2 system utilizes a combination of localized heat and vacuum application to one hand \& forearm; this application opens AVAs in the palm of the hand and warms the extremity thus effectively warming the blood flowing to the body's core.
Arizant Healthcare Bair Hugger Temperature Management SystemDevice
The Bair Hugger system is a forced air system providing convective warming via the circulation of warmed air through specially designed blanket which is placed over a portion of the body
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Use of the Dynatherm Medical vitalHEAT vH2 Temperature Management System to warm patients undergoing orthopedic surgical procedures with an expected duration 2-3 hours and requiring general anesthesia. Receives: Device: vitalHEAT vH2 Temperature Management System |
| 2 | Active comparator | Use of the Arizant Healthcare Bair Hugger Temperature Management System \& Bair Hugger Upper Body Blanket to warm patients undergoing orthopedic surgical procedures with an expected duration 2-3 hours and requiring general anesthesia. Receives: Device: Arizant Healthcare Bair Hugger Temperature Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare esophageal temperatures after 60 minutes of warming with each system
Measured: 60 minutes of patient warming
Secondary outcomes (2)
Compare esophageal temperature trends during surgical procedures
Measured: Every 15 minutes during procedure
Compare sublingual temperatures of patients in PACU
Measured: Within 10 minutes of arrival in PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2008 (estimated)
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic SurgeryStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dynatherm Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kent P Weinmeister, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670826
- Sponsor's protocol ID
- M100 IRB07-003313
- Other IDs
- TP0010C
- Status last verified
- Apr 2008
- First submitted
- 29 Apr 2008
- Last updated
- 2 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHEAT Temperature Management System(vH2)With the Arizant Bair Hugger System
- ClinicalTrials.gov ID
- NCT00670826
- Acronym / sponsor ID
- M100 IRB07-003313
- Conditions
- Orthopedic Surgery, General Anesthesia
- Keywords
- Patient warming
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dynatherm Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 2 May 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.
Medications used to put people to sleep during surgical procedures also cause changes in the body's ability to control its temperature. These changes can make a person's temperature drop below normal. To minimize this drop in body temperature, different types of body warming products are used during surgery. This study is designed to compare the the temperatures of people under general anesthesia after 60 minutes of warming with each product. The study hypothesis is that the people warmed with the Dynatherm Medical vitalHEAT vH2 System will decrease less in the first 60 minutes of warming time than people warmed with the Arizant Bair Hugger System.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: vitalHEAT vH2 Temperature Management SystemUse of the Dynatherm Medical vitalHEAT vH2 Temperature Management System to warm patients undergoing orthopedic surgical procedures with an expected duration 2-3 hours and requiring general anesthesia. |
| 2 | Active comparator | Device: Arizant Healthcare Bair Hugger Temperature Management SystemUse of the Arizant Healthcare Bair Hugger Temperature Management System \& Bair Hugger Upper Body Blanket to warm patients undergoing orthopedic surgical procedures with an expected duration 2-3 hours and requiring general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pts undergoing orthopedic surgical procedure with expected duration 2-3 hrs
- General anesthesia required
- ASA physical status I-III
Key exclusion criteria (5 listed)
- General anesthesia plus epidural anesthesia required
- Skin abrasions/trauma to extremity selected as application site
- History of peripheral vascular disease
- History of malignant hyperthermia
- Unwilling/unable to give consent
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 |
|---|---|---|
| vitalHEAT vH2 Temperature Management SystemThe vH2 system utilizes a combination of localized heat and vacuum application to one hand \& forearm; this application opens AVAs in the palm of the hand and warms the extremity thus effectively warming the blood flowing to the body's core. | Device | 1 |
| Arizant Healthcare Bair Hugger Temperature Management SystemThe Bair Hugger system is a forced air system providing convective warming via the circulation of warmed air through specially designed blanket which is placed over a portion of the body | Device | 2 |
Primary outcome
Compare esophageal temperatures after 60 minutes of warming with each system
Time frame: 60 minutes of patient warming
2 secondary outcomes
Compare esophageal temperature trends during surgical procedures
Time frame: Every 15 minutes during procedure
Compare sublingual temperatures of patients in PACU
Time frame: Within 10 minutes of arrival in PACU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2008.
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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.
Kent P Weinmeister, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitalHEAT vH2 Temperature Management System and Arizant Healthcare Bair Hugger Temperature Management System in people with Orthopedic Surgery and General Anesthesia, run by Dynatherm Medical Inc. 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 3 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 2 May 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kent P Weinmeister, MD (480-342-2446, weinmeister.kent@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare esophageal temperatures after 60 minutes of warming with each system (time frame: 60 minutes of patient warming). 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 2 May 2008.