Efficacy of Warming Device During Surgery

Completed

• Conditions: Surgery
• Interventions: Device: Intraoperative warming with Hotdog resistive heating system; Device: Intraoperative warming with Bair Hugger forced air system

• Registration Number: NCT00715728
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-11
• Study First Submitted QC: 2008-07-11
• Study First Posted: 2008-07-15
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2017-04
• Results First Submitted: 2017-04-18
• Results First Submitted QC: 2017-10-05
• Last Update Submitted: 2017-10-05
• Results First Posted: 2018-07-16
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The Rate of Core Rewarming Over the Range From 35°C to 37°C.	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.
Intraoperative Time Weighted Average Core Temperature	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.

Trial Locations

Locations (1)

Vienna General Hospital/University of Vienna; 🇦🇹 Vienna, Austria