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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00712023
First Posted: July 9, 2008
Last Update Posted: September 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mahidol University
  Purpose
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

Condition Intervention Phase
Hypothermia Vascular Surgery Forced-air Warming Mattress Circulating-water Mattress Device: warming device (a reusable, custom-made forced- air warming mattress) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Forced-air Warming and Circulating-water Mattress in Preventing Heat Loss During Vascular Surgery

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • skin and nasopharyngeal temperature [ Time Frame: 180 min ]

Secondary Outcome Measures:
  • burn wound [ Time Frame: 3 days ]

Enrollment: 44
Study Start Date: July 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
warming by circulating-water mattress
Device: warming device (a reusable, custom-made forced- air warming mattress)

2=forced-air warming mattress

1=circulating-water mattress

No Intervention: 2
Forced-air warming 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients undergoing vascular surgery

Exclusion Criteria:

Preoperative fever

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712023


Locations
Thailand
Departnment of Anesthesiology,Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Suwannee Suraseraniwongse, MD Mahidol University
  More Information

Responsible Party: SUWANNEE SURASERANIVONGSE, Department of Anesthesiology, Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT00712023     History of Changes
Other Study ID Numbers: Si 196/2007
003(1)/50
First Submitted: May 14, 2008
First Posted: July 9, 2008
Last Update Posted: September 29, 2009
Last Verified: April 2008

Keywords provided by Mahidol University:
Hypothermia
Vascular surgery
Forced-air warming mattress
Circulating-water mattress

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms