Efficacy of Warming Device During Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Outcomes Research Consortium.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00715728
First received: July 11, 2008
Last updated: June 18, 2009
Last verified: June 2009
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of a New Intraoperative Resistive Warming Device

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • Primary outcome will be the rate of core rewarming over the range from 35°C to 37°C. [ Time Frame: Intraoperative/5 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Intraoperative warming with Bair Hugger forced air system
2
Intraoperative warming with Hot Dog resistive heating system

Detailed Description:

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
Study Population

Patients undergoing major plastic surgery lasting approximately 5 hours.

Criteria

Inclusion Criteria:

  • Plastic surgery lasting approximately 5 hours
  • Subjects over the age of 18 years
  • Patient signed Informed Consent

Exclusion Criteria:

  • Plastic surgery lasting less than 5 hours
  • Individuals under the age of 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715728

Contacts
Contact: Olga Plattner, MD olga.plattner@meduniwien.ac.at

Locations
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         
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Olga Plattner, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Olga Plattner, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00715728     History of Changes
Other Study ID Numbers: IRWS
Study First Received: July 11, 2008
Last Updated: June 18, 2009
Health Authority: Austria: Ethikkommission

Keywords provided by Outcomes Research Consortium:
Plastic surgery
Warming
Core temperature
Bair Hugger
Hot Dog heating system

ClinicalTrials.gov processed this record on September 18, 2014