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

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00712023
First received: May 14, 2008
Last updated: September 27, 2009
Last verified: April 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • burn wound [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients undergoing vascular surgery

Exclusion Criteria:

Preoperative fever

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 14, 2008
Last Updated: September 27, 2009
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on August 19, 2014