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Efficacy of Warming Device During Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00715728
Recruitment Status : Completed
First Posted : July 15, 2008
Results First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
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 or disease Intervention/treatment
Surgery Device: Intraoperative warming with Bair Hugger forced air system Device: Intraoperative warming with Hotdog 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.

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of a New Intraoperative Resistive Warming Device
Study Start Date : June 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Group/Cohort Intervention/treatment
1: Bair Hugger
Intraoperative warming with Bair Hugger forced air system
Device: Intraoperative warming with Bair Hugger forced air system
Intraoperative warming with Bair Hugger forced air system

2: Hot Dog
Intraoperative warming with Hot Dog resistive heating system
Device: Intraoperative warming with Hotdog resistive heating system
Intraoperative warming with Hotdog resistive heating system




Primary Outcome Measures :
  1. The Rate of Core Rewarming Over the Range From 35°C to 37°C. [ Time Frame: Until the end of surgery, up to 5 hour ]
    The primary outcome was the rewarming rate during active heating over a core temperature range from 35°C to 37°C.

  2. Intraoperative Time Weighted Average Core Temperature [ Time Frame: Until the end of surgery, up to 5 hour ]
    Temperatures during surgery were recorded at 15-min intervals and summarize as time weighted average (TWA) for each patient. The unit of TWA-temperature is °C.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715728


Locations
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Austria
Vienna General Hospital/University of Vienna
Vienna, Austria
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Olga Plattner, MD Medical University of Vienna
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00715728    
Other Study ID Numbers: IRWS
First Posted: July 15, 2008    Key Record Dates
Results First Posted: July 16, 2018
Last Update Posted: July 16, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Cleveland Clinic:
Plastic surgery
Warming
Core temperature
Bair Hugger
Hot Dog heating system