Efficacy of Warming Device During Surgery

NCT00715728 | Completed Results

• 1 other identifier: IRWS
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

Plastic surgery; Warming; Core temperature; Bair Hugger; Hot Dog heating system

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

1: Bair Hugger

Intraoperative warming with Bair Hugger forced air system

Device: 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

Interventions

Intraoperative warming with Bair Hugger forced air system DEVICE

Intraoperative warming with Bair Hugger forced air system

1: Bair Hugger

Intraoperative warming with Hotdog resistive heating system DEVICE

Intraoperative warming with Hotdog resistive heating system

2: Hot Dog

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing major plastic surgery lasting approximately 5 hours.

You may qualify if:

• Plastic surgery lasting approximately 5 hours
• Subjects over the age of 18 years
• Patient signed Informed Consent

You may not qualify if:

• Plastic surgery lasting less than 5 hours
• Individuals under the age of 18 years

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Vienna General Hospital/University of Vienna

Vienna, Austria

Location

Limitations and Caveats

Unable to evaluate safety with small sample size. Smaller-than-expected sample size had enough power but confidence intervals for treatment effect wider than desired.

Results Point of Contact

• Title: Olga Plattner, Medical Doctor
• Organization: Vienna General Hospital/University of Vienna

olga.plattner@meduniwien.ac.at

43-1-40-400-4103

Study Officials

• Olga Plattner, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 15, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 16, 2018
• Results First Posted: July 16, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)