Back to resultsA Comparison of Prevention of Hypothermia in Pediatric Patient Between Wrapping With Cotton and Plastic.
Primary Purpose
Perioperative Hypotension, Prevention, Child
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Plastic wrap (study group) and cotton (control group) wrap.
Sponsored by
About this trial
This is an interventional prevention trial for Perioperative Hypotension focused on measuring Prevention of Hypothermia, Pediatric Patient, Cotton, Plastic wrap
Eligibility Criteria
Inclusion Criteria: 42 pediatric patients (age 1 month-3 years ASA physical status 1-2) who were scheduled for elective maxillofacial or genitourinary surgery. Exclusion Criteria:
Sites / Locations
- Warporn Chau-in
Outcomes
Primary Outcome Measures
Core temperature
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00231699
Brief Title
A Comparison of Prevention of Hypothermia in Pediatric Patient Between Wrapping With Cotton and Plastic.
Official Title
A Comparison of Prevention of Hypothermia in Pediatric Patient Between Wrapping With Cotton (Webril) and Plastic (Mwrap).
Study Type
Interventional
2. Study Status
Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Khon Kaen University
4. Oversight
5. Study Description
Brief Summary
Hypothermia leads to increased morbidity and mortality. Heat loss mainly occurs during anesthesia and surgery. Therefore prevention of hypothermia in pediatric patients undergoing general anesthesia is very important. However, there is very little information about effectiveness of various insulating materials used in the operating room.
Objective: To compare the effectiveness of cotton and plastic for prevent intraoperative hypothermia in pediatric patients.
Detailed Description
A randomized controlled trial was conducted in 42 pediatric patients (age 1 month-3 years, ASA physical status 1-2) who were scheduled for elective maxillofacial or genitourinary surgery. The patients were randomly allocated into 2 groups. The patient's arms, legs and bodies were wrapped with either plastic (study group) or cotton (control group). All patients received standard general anesthesia with endotracheal tube and control ventilation with a fresh gas flow at 1 l/min. The core temperature (rectal temperature) was recorded every 10 minutes for 60 minutes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative Hypotension, Prevention, Child
Keywords
Prevention of Hypothermia, Pediatric Patient, Cotton, Plastic wrap
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
42 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Plastic wrap (study group) and cotton (control group) wrap.
Primary Outcome Measure Information:
Title
Core temperature
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
42 pediatric patients (age 1 month-3 years
ASA physical status 1-2) who were scheduled for elective maxillofacial or genitourinary surgery.
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
waraporn chau-in, Asso Prof.
Organizational Affiliation
Faculty of Medicine,KhonKaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warporn Chau-in
City
KhonKaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Prevention of Hypothermia in Pediatric Patient Between Wrapping With Cotton and Plastic.
We'll reach out to this number within 24 hrs