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| Sponsored by: |
Outcomes Research Consortium |
|---|---|
| Information provided by: | Outcomes Research Consortium |
| ClinicalTrials.gov Identifier: | NCT00715728 |
Purpose
This study will test the hypothesis that an electric heating device, the Hot Dog warming system is as effective as the Bair Hugger forced air heating system.
| Condition |
|---|
|
Surgery |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Efficacy of a New Intraoperative Resistive Warming Device |
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Intraoperative warming with Bair Hugger forced air system
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|
2
Intraoperative warming with Hot Dog resistive heating system
|
Subjects undergoing major plastic surgery lasting approximately 5 hours will be randomized to either the Hot Dog resistive heating system or the Bair Hugger forced air heating system. Core temperature will be measured using a distal esophagus and mean skin temperature. Warming will continue until the subjects' core temperature reaches 37°C. Subsequent temperature will be adjusted as clinically necessary. Data will be recorded at 15 minute intervals. Core temperature will be first measured after intubation when the esophageal temperature probe is inserted. The primary outcome will be the rate of core rewarming over the range of 35°C to 37°C.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients undergoing major plastic surgery lasting approximately 5 hours.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Olga Plattner, MD | olga.plattner@meduniwien.ac.at |
| Austria | |
| Vienna General Hospital/University of Vienna | Recruiting |
| Vienna, Austria | |
| Contact: Olga Plattner, MD 43-1-40-400-4103 ethik-dom@meduniview.ac.at | |
| Sub-Investigator: Daniel I Sessler, MD | |
| Principal Investigator: | Olga Plattner, MD | Medical University of Vienna |
More Information
| Responsible Party: | Medical University of Vienna ( Olga Plattner ) |
| Study ID Numbers: | IRWS |
| Study First Received: | July 11, 2008 |
| Last Updated: | October 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00715728 |
| Health Authority: | Austria: Ethikkommission |
|
Plastic surgery Warming Core temperature Bair Hugger Hot Dog heating system |
