A Comparison of Prevention of Hypothermia in Pediatric Patient Between Wrapping With Cotton and Plastic.

Child Clinical Trial

Official title:

A Comparison of Prevention of Hypothermia in Pediatric Patient Between Wrapping With Cotton (Webril) and Plastic (Mwrap).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231699
• Other study ID #: Prevention of Hypothermia
• Status: Completed
• Phase: N/A
• First received: October 3, 2005
• Last updated: October 3, 2005
• Start date: January 2004
• Est. completion date: December 2004

Study information

• Verified date: October 2005
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 3 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child
• Hypotension
• Hypothermia
• Perioperative Hypotension
• Prevention

Intervention

Procedure:
• Plastic wrap (study group) and cotton (control group) wrap.

Locations

Country	Name	City	State
Thailand	Warporn Chau-in	KhonKaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core temperature