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Completed

NCT Number: NCT00715728

Efficacy of Warming Device During Surgery

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.

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vienna General Hospital/University of Vienna

Vienna, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoperative warming with Bair Hugger forced air system

Device

Intraoperative warming with Bair Hugger forced air system

Intraoperative warming with Hotdog resistive heating system

Device

Intraoperative warming with Hotdog resistive heating system

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Efficacy of a New Intraoperative Resistive Warming Device

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 15, 2008
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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