A Comparison of Prevention of Hypothermia in Pediatric Pa... | NCT00231699

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

NCT00231699

Sponsor

Khon Kaen University

Status

Completed

Last Update Posted

Oct 4, 2005Estimated

Enrollment

Phase

Not Applicable

Conditions

Perioperative Hypotension
Prevention
Child

Interventions

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

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Dec 2004

First Submitted Date

Oct 3, 2005

First Submission Date that Met QC Criteria

Oct 3, 2005

First Posted Date

Oct 4, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2005

Last Update Posted Date

Oct 4, 2005Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Plastic wrap (study group) and cotton (control group) wrap.	Procedure

Measure	Description	Time Frame
Core temperature

Eligibility Module

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:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

3 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
waraporn chau-in, Asso Prof.	Faculty of Medicine,KhonKaen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Warporn Chau-in		KhonKaen	KhonKaen	40002	Thailand

Intervention Browse Module

MeSH Terms

ID	Term
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided