Efficacy of Warming Device During Surgery

Efficacy of a New Intraoperative Resistive Warming Device

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: Intraoperative warming with Bair Hugger forced air system; Device: Intraoperative warming with Hotdog resistive 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 Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Vienna General Hospital/University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing major plastic surgery lasting approximately 5 hours.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1: Bair Hugger; Intraoperative warming with Bair Hugger forced air system	Device: Intraoperative warming with Bair Hugger forced air system; Intraoperative warming with Bair Hugger forced air system
2: Hot Dog; Intraoperative warming with Hot Dog resistive heating system	Device: Intraoperative warming with Hotdog resistive heating system; Intraoperative warming with Hotdog resistive heating system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Olga Plattner, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: July 11, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 15, 2008

Study Record Updates

• Last Update Posted (Actual): July 16, 2018
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Plastic surgery; Warming; Core temperature; Bair Hugger; Hot Dog heating system
• Other Study ID Numbers: IRWS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No