Efficacy of Warming Device During Surgery

Surgery Clinical Trial

Official title:

Efficacy of a New Intraoperative Resistive Warming Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715728
• Other study ID #: IRWS
• Status: Completed
• Start date: June 2008
• Est. completion date: December 2009

Study information

• Verified date: April 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

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

Locations

Country	Name	City	State
Austria	Vienna General Hospital/University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Rate of Core Rewarming Over the Range From 35°C to 37°C.	The primary outcome was the rewarming rate during active heating over a core temperature range from 35°C to 37°C.	Until the end of surgery, up to 5 hour
Primary	Intraoperative Time Weighted Average Core Temperature	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.	Until the end of surgery, up to 5 hour