Efficacy of Warming Device During Surgery

NCT ID: NCT00715728

Last Updated: 2018-07-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1: Bair Hugger

Intraoperative warming with Bair Hugger forced air system

Intraoperative warming with Bair Hugger forced air system

Intervention Type DEVICE

Intraoperative warming with Bair Hugger forced air system

2: Hot Dog

Intraoperative warming with Hot Dog resistive heating system

Intraoperative warming with Hotdog resistive heating system

Intervention Type DEVICE

Intraoperative warming with Hotdog resistive heating system

Interventions

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Intraoperative warming with Bair Hugger forced air system

Intraoperative warming with Bair Hugger forced air system

Intervention Type DEVICE

Intraoperative warming with Hotdog resistive heating system

Intraoperative warming with Hotdog resistive heating system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olga Plattner, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Vienna General Hospital/University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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IRWS

Identifier Type: -

Identifier Source: org_study_id

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