Efficacy of Warming Device During Surgery

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NeuroTherapia, Inc.

Status

Completed

Conditions

Surgery

Treatments

Device: Intraoperative warming with Hotdog resistive heating system
Device: Intraoperative warming with Bair Hugger forced air system

Study type

Observational

Funder types

Other

Identifiers

NCT00715728
IRWS

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

28 participants in 2 patient groups

1: Bair Hugger
Description:
Intraoperative warming with Bair Hugger forced air system
Treatment:
Device: Intraoperative warming with Bair Hugger forced air system
2: Hot Dog
Description:
Intraoperative warming with Hot Dog resistive heating system
Treatment:
Device: Intraoperative warming with Hotdog resistive heating system

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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