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

Primary Purpose

Hypothermia, Vascular Surgery, Forced-air Warming Mattress

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
warming device (a reusable, custom-made forced- air warming mattress)
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia focused on measuring Hypothermia, Vascular surgery, Forced-air warming mattress, Circulating-water mattress

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients undergoing vascular surgery

Exclusion Criteria:

Preoperative fever

Sites / Locations

  • Departnment of Anesthesiology,Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

warming by circulating-water mattress

Forced-air warming mattress

Outcomes

Primary Outcome Measures

skin and nasopharyngeal temperature

Secondary Outcome Measures

burn wound

Full Information

First Posted
May 14, 2008
Last Updated
September 27, 2009
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT00712023
Brief Title
Effect of Forced-air Warming and Circulating-water Mattress in Preventing Heat Loss During Vascular Surgery
Official Title
Effect of Forced-air Warming and Circulating-water Mattress in Preventing Heat Loss During Vascular Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Vascular Surgery, Forced-air Warming Mattress, Circulating-water Mattress
Keywords
Hypothermia, Vascular surgery, Forced-air warming mattress, Circulating-water mattress

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
warming by circulating-water mattress
Arm Title
2
Arm Type
No Intervention
Arm Description
Forced-air warming mattress
Intervention Type
Device
Intervention Name(s)
warming device (a reusable, custom-made forced- air warming mattress)
Intervention Description
2=forced-air warming mattress 1=circulating-water mattress
Primary Outcome Measure Information:
Title
skin and nasopharyngeal temperature
Time Frame
180 min
Secondary Outcome Measure Information:
Title
burn wound
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients undergoing vascular surgery Exclusion Criteria: Preoperative fever
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suwannee Suraseraniwongse, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departnment of Anesthesiology,Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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

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