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Intraoperative Warming Comparison of Devices

This study is not yet open for participant recruitment.
Study NCT00650260.   Last updated on March 31, 2008.   Information provided by University of South Florida

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Descriptive Information Fields
Brief Title  Intraoperative Warming Comparison of Devices
Official Title  Intraoperative Warming : Comparison of Performance of the Dynatherm Medical vitalHEAT™ Temperature Management System (vH2) and the Arizant Bair Hugger System
Brief 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.

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.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Prevention, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  The critical endpoints to be evaluated in making this determination are 1) % of subjects with an average intraoperative esophageal temperature of ≥ 36º C [ Time Frame: During surgical procedure ] [ Designated as safety issue: Yes ]
% of subjects with an initial PACU sublingual temperature of ≥ 36º C. [ Time Frame: Temp taken just prior to surgery ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  comparison of the core body temperatures @ 60 minutes post anesthesia induction, [ Time Frame: 60 minutes post anesthesia induction ] [ Designated as safety issue: Yes ]
comparison of temperature trends during surgery [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]
comparison of the subjects' PACU temperature trends and hypothermic symptoms such as shivering [ Time Frame: Within an hour after surgery ] [ Designated as safety issue: Yes ]
Condition  Hypothermia
Intervention  Device: Dynatherm Medical vitalHEAT Temperature Management System vH2
Device: Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)
MEDLINE PMIDs 17342966,   10691247,   15114200,   8141463
Links
Recruitment Information Fields
Recruitment Status  Not yet recruiting
Enrollment  40
Start Date  April 2008
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Gender Both
Ages 18 Years to 80 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00650260
Organization ID IRB 106411c
Secondary IDs †† TGH 100, USF 6176-P67639
Study Sponsor  University of South Florida
Collaborators †† Dynatherm Medical Inc.
Investigators 
Principal Investigator:     Enrico M Camporesi, M.D.     University of South Florida    
Information Provided By University of South Florida
Verification Date March 2008
First Received Date  March 27, 2008
Last Updated Date March 31, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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