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NCT00650260 · ClinicalTrials.gov registry record · NA
Intraoperative Warming Comparison of Devices
A NA study, sponsored by University of South Florida.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
NCT00650260 is a NA study that has completed, run by University of South Florida. The registered enrollment target is 42 participants.
The verdict
NCT00650260, a NA study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
Study 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. 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
Interventions
- DEVICE Dynatherm Medical vitalHEAT Temperature Management System vH2
- DEVICE Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2009-02 |
| Est. Completion | 2009-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00650260
The ClinicalTrials.gov registry entry for NCT00650260 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dynatherm Medical vitalHEAT Temperature Management System vH2 is the first listed.
NCT00650260 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00650260 about?
NCT00650260 is a clinical study titled "Intraoperative Warming Comparison of Devices". 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 ...
What is the current status of trial NCT00650260?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2009-02. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00650260?
The interventions under investigation include: Dynatherm Medical vitalHEAT Temperature Management System vH2 (DEVICE), Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN) (DEVICE).
Who is sponsoring clinical trial NCT00650260?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
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