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| Sponsors and Collaborators: |
University of South Florida Dynatherm Medical Inc. |
| Information provided by: | University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00650260 |
Purpose
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. 5, 6 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. 7, 8, 9 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 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 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 PACU 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' PACU temperature trends and hypothermic symptoms such as shivering.
| Condition | Intervention |
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Hypothermia |
Device: Dynatherm Medical vitalHEAT Temperature Management System vH2 Device: Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN) |
| MedlinePlus related topics: | Anesthesia Hypothermia |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Intraoperative Warming : Comparison of Performance of the Dynatherm Medical vitalHEAT™ Temperature Management System (vH2) and the Arizant Bair Hugger System |
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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vH2 System Group: Experimental
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. The 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.
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Device: Dynatherm Medical vitalHEAT Temperature Management System vH2
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.
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Control Group: Active Comparator
The Bair Hugger system is the current standard of care at TGH. 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.
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Device: Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)
The Bair Hugger system is the current standard of care at TGH. 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.
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Eligibility
| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |||||
| Tampa General Hospital | Not yet recruiting | ||||
| Tampa, Florida, United States, 33606 | |||||
| Contact: Anna Valencia, MPH 813-844-7000 avalencia@tgh.org | |||||
| Principal Investigator: Enrico M Camporesi, M.D | |||||
| University of South Florida |
| Dynatherm Medical Inc. |
| Principal Investigator: | Enrico M Camporesi, M.D. | University of South Florida |
More Information
| Responsible Party: | Department of Anesthesiology, University of South Florida ( Enrico Camporesi ) |
| Study ID Numbers: | IRB 106411c, TGH 100, USF 6176-P67639 |
| First Received: | March 27, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00650260 |
| Health Authority: | United States: Institutional Review Board |
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