HypothermiaNCT00650260
Intraoperative Warming Comparison of Devices
A study testing Dynatherm Medical vitalHEAT Temperature Management System vH2 and Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN) in people with Hypothermia, run by University of South Florida at 1 site in United States.
Trial summary
Hypothermia is a common and serious complication during anesthesia and surgery. Anesthetic-induced hypothermia results from the inhibition of thermoregulatory control and exposure to cold operating room environment. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia
- What is being tested?
- Dynatherm Medical vitalHEAT Temperature Management System vH2 and Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Aug 2009
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing elective open abdominal surgical procedures with an expected duration of 2 to 4 hours and requiring general anesthesia
- American Society of Anesthesiologists(ASA) physical status I-III
- Patient age: > 18 years and <80 years
Who cannot join
- Patient age: < 18 years and >80 years
- Patients with break in skin integrity on the extremity selected as the application site
- Patients with history of upper extremity peripheral vascular disease
- Patients with history of allergic skin conditions of the upper extremities
- Patients with history of bleeding disorders/coagulopathy
- Patient with history of malignant hyperthermia
- Patients who are pregnant
- Patient unwilling or unable to give informed 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) and the Arizant Bair Hugger System
Hypothermia is a common and serious complication during anesthesia and surgery. Anesthetic-induced hypothermia results from the inhibition of thermoregulatory control and exposure to cold operating room environment.
Various warming methods, such as warm blankets, forced-air warmers and circulating water mattresses, are currently used to prevent and treat mild perioperative hypothermia. All are cutaneous approaches that rely on heating the peripheral tissues in order to increase the thermal core temperature. Application of cutaneous warming system blankets/pads are limited by location/extent of operative site; for example, in certain procedures such as laparatomies, reconstructive plastic surgery or orthopedic surgery, only a limited amount of skin surface is available for warming application. The Dynatherm vitalHEAT technology takes advantage of the body's natural thermoregulatory system to channel thermal energy to the body's core non-invasively at a rapid rate. The vital heat (vH2) system is designed to treat hypothermia during the peri-operative period through a combination of localized heat and vacuum application to one hand \& forearm; this application 1) opens the arteriovenous anastamoses located in the palm of the hand and 2) conductively warms the extremity thus effectively warming the blood flow to the body's core. The vital heat vH2 system is a portable and compact warming device which provides a non-invasive approach to warming patients during surgery.
The primary objective of this study is to determine if the Dynatherm Medical vitalHEAT (vH2) Temperature Management System is as effective as the forced-air warming Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN) for maintenance of intraoperative body temperature in patients undergoing abdominal surgery under general anesthesia. The critical endpoints to be evaluated in making this determination are 1) % of subjects with an average intraoperative esophageal temperature of ≥ 36º C and 2) % of subjects with an initial post anesthesia care unit sublingual temperature of ≥ 36º C. Secondary objectives include 1) comparison of the core body temperatures @ 60 minutes post anesthesia induction, 2) comparison of temperature trends during surgery and 3) comparison of the subjects' post anesthesia care unit temperature trends and hypothermic symptoms such as shivering.
- Conditions
- Hypothermia
- Being tested
- Dynatherm Medical vitalHEAT Temperature Management System vH2, Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)
- Keywords
- intraoperative warming, anesthesia, hypothermia, body temperature
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynatherm Medical vitalHEAT Temperature Management System vH2Device
Also called Part number VH-200
The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical.
Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)Device
Also called Model 522
The Bair Hugger system is the current standard of care at Tampa General Hospital. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket.
| Study group | Role | What they receive |
|---|---|---|
| vH2 System Group | Experimental | The vital heat vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vital heat vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection. Receives: Device: Dynatherm Medical vitalHEAT Temperature Management System vH2 |
| Control Group | Active comparator | The Bair Hugger system is the current standard of care at Tampa General Hospital. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection. Receives: Device: Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients With an Average Intraoperative Temperature Greater Than or Equal to 36 Celcius
Measured: Intraoperative Period
Percent of Subjects With an Initial PACU Sublingual Temperature of ≥ 36º C.
Measured: Temp taken just prior to surgery
Percentage of Patients With a Post Operative Sublingual Temperature Above 36 Degrees Celcius
Percent of subjects with an initial post anesthesia care unit sublingual temperature of ≥ 36º C
Measured: Upon entry to the post anesthesia care unit
Secondary outcomes (3)
Comparison of the Core Body Temperatures at 60 Minutes Post Anesthesia Induction,as Assessed by Esophageal Probe.
Average core body temperature measured with an esophageal probe at 60 minutes post-induction
Measured: 60 minutes post anesthesia induction
Average Intraoperative Esophageal Temperature
Average esophageal temperature for the first 70 minutes of surgery following induction of anesthesia.
Measured: Intraoperative 0-70 minutes
Median Post Anesthesia Care Unit Sublingual Temperature
Measured: Upon arrival to the post anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionAug 2009
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Dynatherm Medical Inc.
- Responsible party
- Principal investigator, Enrico Camporesi, University of South Florida
- Investigators
- Enrico M Camporesi, M.D., Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650260
- Sponsor's protocol ID
- IRB 106411c
- Other IDs
- TGH 100, USF 6176-P67639
- Status last verified
- Sep 2012
- First submitted
- 27 Mar 2008
- Last updated
- 29 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin. 2006 Dec;24(4):823-37. doi: 10.1016/j.atc.2006.09.001.
PubMed 17342966Sessler DI. Perioperative heat balance. Anesthesiology. 2000 Feb;92(2):578-96. doi: 10.1097/00000542-200002000-00042.
PubMed 10691247Taguchi A, Ratnaraj J, Kabon B, Sharma N, Lenhardt R, Sessler DI, Kurz A. Effects of a circulating-water garment and forced-air warming on body heat content and core temperature. Anesthesiology. 2004 May;100(5):1058-64. doi: 10.1097/00000542-200405000-00005.
PubMed 15114200Giesbrecht GG, Ducharme MB, McGuire JP. Comparison of forced-air patient warming systems for perioperative use. Anesthesiology. 1994 Mar;80(3):671-9. doi: 10.1097/00000542-199403000-00026.
PubMed 8141463
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. 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) and the Arizant Bair Hugger System
- ClinicalTrials.gov ID
- NCT00650260
- Acronym / sponsor ID
- IRB 106411c
- Conditions
- Hypothermia
- Keywords
- intraoperative warming, anesthesia, hypothermia, body temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Dynatherm Medical Inc.
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Posted 29 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothermia is a common and serious complication during anesthesia and surgery. Anesthetic-induced hypothermia results from the inhibition of thermoregulatory control and exposure to cold operating room environment.
Various warming methods, such as warm blankets, forced-air warmers and circulating water mattresses, are currently used to prevent and treat mild perioperative hypothermia. All are cutaneous approaches that rely on heating the peripheral tissues in order to increase the thermal core temperature. Application of cutaneous warming system blankets/pads are limited by location/extent of operative site; for example, in certain procedures such as laparatomies, reconstructive plastic surgery or orthopedic surgery, only a limited amount of skin surface is available for warming application. The Dynatherm vitalHEAT technology takes advantage of the body's natural thermoregulatory system to channel thermal energy to the body's core non-invasively at a rapid rate. The vital heat (vH2) system is designed to treat hypothermia during the peri-operative period through a combination of localized heat and vacuum application to one hand \& forearm; this application 1) opens the arteriovenous anastamoses located in the palm of the hand and 2) conductively warms the extremity thus effectively warming the blood flow to the body's core. The vital heat vH2 system is a portable and compact warming device which provides a non-invasive approach to warming patients during surgery.
The primary objective of this study is to determine if the Dynatherm Medical vitalHEAT (vH2) Temperature Management System is as effective as the forced-air warming Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN) for maintenance of intraoperative body temperature in patients undergoing abdominal surgery under general anesthesia. The critical endpoints to be evaluated in making this determination are 1) % of subjects with an average intraoperative esophageal temperature of ≥ 36º C and 2) % of subjects with an initial post anesthesia care unit sublingual temperature of ≥ 36º C. Secondary objectives include 1) comparison of the core body temperatures @ 60 minutes post anesthesia induction, 2) comparison of temperature trends during surgery and 3) comparison of the subjects' post anesthesia care unit temperature trends and hypothermic symptoms such as shivering.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vH2 System Group | Experimental | Device: Dynatherm Medical vitalHEAT Temperature Management System vH2The vital heat vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vital heat vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection. |
| Control Group | Active comparator | Device: Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)The Bair Hugger system is the current standard of care at Tampa General Hospital. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective open abdominal surgical procedures with an expected duration of 2 to 4 hours and requiring general anesthesia
- American Society of Anesthesiologists(ASA) physical status I-III
- Patient age: > 18 years and <80 years
Key exclusion criteria (8 listed)
- Patient age: < 18 years and >80 years
- Patients with break in skin integrity on the extremity selected as the application site
- Patients with history of upper extremity peripheral vascular disease
- Patients with history of allergic skin conditions of the upper extremities
- Patients with history of bleeding disorders/coagulopathy
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 |
|---|---|---|
| Dynatherm Medical vitalHEAT Temperature Management System vH2Also: Part number VH-200The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. | Device | vH2 System Group |
| Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)Also: Model 522The Bair Hugger system is the current standard of care at Tampa General Hospital. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. | Device | Control Group |
Primary outcome
Percent of Patients With an Average Intraoperative Temperature Greater Than or Equal to 36 Celcius
Time frame: Intraoperative Period
Percent of Subjects With an Initial PACU Sublingual Temperature of ≥ 36º C.
Time frame: Temp taken just prior to surgery
Percentage of Patients With a Post Operative Sublingual Temperature Above 36 Degrees Celcius
Time frame: Upon entry to the post anesthesia care unit
Percent of subjects with an initial post anesthesia care unit sublingual temperature of ≥ 36º C
3 secondary outcomes
Comparison of the Core Body Temperatures at 60 Minutes Post Anesthesia Induction,as Assessed by Esophageal Probe.
Time frame: 60 minutes post anesthesia induction
Average Intraoperative Esophageal Temperature
Time frame: Intraoperative 0-70 minutes
Median Post Anesthesia Care Unit Sublingual Temperature
Time frame: Upon arrival to the post anesthesia care unit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17342966Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin. 2006 Dec;24(4):823-37. doi: 10.1016/j.atc.2006.09.001.
- Background: PubMed 10691247Sessler DI. Perioperative heat balance. Anesthesiology. 2000 Feb;92(2):578-96. doi: 10.1097/00000542-200002000-00042.
- Background: PubMed 15114200Taguchi A, Ratnaraj J, Kabon B, Sharma N, Lenhardt R, Sessler DI, Kurz A. Effects of a circulating-water garment and forced-air warming on body heat content and core temperature. Anesthesiology. 2004 May;100(5):1058-64. doi: 10.1097/00000542-200405000-00005.
- Background: PubMed 8141463Giesbrecht GG, Ducharme MB, McGuire JP. Comparison of forced-air patient warming systems for perioperative use. Anesthesiology. 1994 Mar;80(3):671-9. doi: 10.1097/00000542-199403000-00026.
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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.
Enrico M Camporesi, M.D. principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynatherm Medical vitalHEAT Temperature Management System vH2 and Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN) in people with Hypothermia, run by University of South Florida 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 8 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 29 Oct 2012. 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 29 Oct 2012). 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?
Percent of Patients With an Average Intraoperative Temperature Greater Than or Equal to 36 Celcius (time frame: Intraoperative Period). The study lists 3 primary outcomes in all. 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 NCT00650260, which also lists 4 linked publications.
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 29 Oct 2012.