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NCT00712023 Clinical Trial

Effect of Forced-air Warming and Circulating-water Mattress in Preventing Heat Loss During Vascular Surgery

Hypothermia Clinical Trial

Official title:
Effect of Forced-air Warming and Circulating-water Mattress in Preventing Heat Loss During Vascular Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00712023
Other study ID # Si 196/2007
Secondary ID 003(1)/50
Status Completed
Phase Phase 2
First received May 14, 2008
Last updated September 27, 2009
Start date July 2007
Est. completion date September 2008

Study information
Verified date April 2008
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a custom-made forced-air warming mattress can prevent heat loss in patients undergoing vascular surgery better than a circulating-water mattress

Description:

A reusable, custom-made forced-air warming mattress was made of a light to medium weight water resistant canvas, sewn like mattress with 2 arms placed underneath the patient. An open hole at proximal part of one arm was designed to attach with a hose of warm air delivery device. Small holes (2-3 mm2), 5 inches apart were punched on the upper surface of this mattress around the patient except for the area underneath the patient that the holes were 9 inches apart. The weight of the patient will obstruct the air flow and prevent direct blowing of warm air onto the underside of patients. There is a special appendage connected to the upper part of mattress which can connect warm air to cover the patient's chest. There is a special appendage connected to the upper part of mattress which can convect warm air to cover the patient's chest. The mattress is 97 inches x 97 inches, with 2 arms of 25 inches x 16 inches and a special appendage of 45 inches x 12 inches for covering the chest with warm air delivery. This size is proper for patient of 170 cm. height. In order to reuse it, the mattress can be washed, dried and sterilized by gas or autoclaved for more than 50 times. A sterile sheet well enhance the sterile environment of the operating field.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria:

Patients undergoing vascular surgery

Exclusion Criteria:

Preoperative fever

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• warming device (a reusable, custom-made forced- air warming mattress)
2=forced-air warming mattress 1=circulating-water mattress

Locations
Country Name City State
Thailand Departnment of Anesthesiology,Siriraj Hospital, Mahidol University Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary skin and nasopharyngeal temperature 180 min Yes
Secondary burn wound 3 days Yes
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