Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming

NCT01075724 | Completed Phase 3

• 1 other identifier: HDBH3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative active warming is usually performed by skin warming. There are several forced-air systems on the market; forced air warming is generally described as the most effective yet feasible method of patient warming. Augustine Biomedical (Eden Prairie, MN, USA) recently introduced a new patient warming system named "Hot Dog" with an active polymer warming upper-body blanket and a new under-body warming mattress. The polymer-heating devices consist of an electronic regulator and the polymer blankets, which are covered with a washable fabric. Conventional mains power the system. The manufacturer claims, that the new system "Hot Dog" (with combination of under body and upper body warming) is as effective as forced air warming, while not having any disadvantages of the forced air system, like: airborne infection, noise, high power consumption and hard-to-clean hose. The investigators will compare the new Hot Dog patient warming device combination (under body + upper body) with the established warming system, which blows warm air via a mattress over the body of the patients).

Conditions

Hypothermia

Keywords

Perioperative Hypothermia Prevention; Accidental Perioperative Hypothermia

Outcome Measures

Primary Outcomes (1)

• Core Temperature at the end of surgery (at time of skin suture)

  Single Measurement at Beginning of Skin Suture

Secondary Outcomes (1)

• Core temperature increase (°C/time)

  From Beginning until End of Surgery

Study Arms (2)

Forced air

ACTIVE COMPARATOR

Forced Air Warming

Device: Patient Warming with Forced Air

Resistive HotDog Warming

EXPERIMENTAL

Warming by resistive Warming

Device: Resistive Warming

Interventions

Patient Warming with Forced Air DEVICE

Forced Air warming via BairHugger

Forced air

Resistive Warming DEVICE

Resistive Warming via HotDog device

Resistive HotDog Warming

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The investigators will study 40 patients (18-90 years) undergoing elective orthopedic lower limb surgery at the trauma surgery unit. The patients must have normal weight (20-30 BMI), the duration of surgery should last between 2 - 3 hours.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Oliver Kimberger

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.PD Dr. MSc

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: February 25, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

AU (1)