NCT00231699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
Last Updated

October 4, 2005

Status Verified

October 1, 2005

First QC Date

October 3, 2005

Last Update Submit

October 3, 2005

Conditions

Perioperative HypotensionPreventionChild

Keywords

Prevention of HypothermiaPediatric PatientCottonPlastic wrap

Outcome Measures

Primary Outcomes (1)

  • Core temperature

Interventions

Plastic wrap (study group) and cotton (control group) wrap.PROCEDURE

Eligibility Criteria

Age1 Month - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • pediatric patients (age 1 month-3 years
  • ASA physical status 1-2) who were scheduled for elective maxillofacial or genitourinary surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warporn Chau-in

KhonKaen, KhonKaen, 40002, Thailand

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • waraporn chau-in, Asso Prof.

    Faculty of Medicine,KhonKaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 4, 2005

Study Start

January 1, 2004

Study Completion

December 1, 2004

Last Updated

October 4, 2005

Record last verified: 2005-10

Locations

TH(1)