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

NCT ID: NCT00712023

Last Updated: 2009-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-09-30

Brief 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

Detailed 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.

Conditions

Hypothermia; Vascular Surgery; Forced-air Warming Mattress; Circulating-water Mattress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

warming by circulating-water mattress

Group Type: ACTIVE_COMPARATOR

warming device (a reusable, custom-made forced- air warming mattress)

Intervention Type: DEVICE

2=forced-air warming mattress

1=circulating-water mattress

2

Forced-air warming mattress

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

warming device (a reusable, custom-made forced- air warming mattress)

2=forced-air warming mattress

1=circulating-water mattress

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Patients undergoing vascular surgery

Exclusion Criteria

Preoperative fever

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Department of Anesthesiology, Siriraj Hospital, Mahidol University

Principal Investigators

Suwannee Suraseraniwongse, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Departnment of Anesthesiology,Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

003(1)/50

Identifier Type: -

Identifier Source: secondary_id

Si 196/2007

Identifier Type: -

Identifier Source: org_study_id