Back to resultsChanges of Body Temperature During Shoulder Arthroscopy
Primary Purpose
Hypothermia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
heated circuit
control
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia focused on measuring heated circuit, body temperature
Eligibility Criteria
Inclusion Criteria:
- American society of anesthesiologist physical status 1 or 2
- 20-60 years old
Exclusion Criteria:
- body mass index over 30 kg/m2
- peripheral vascular disease
- uncontrolled cardiovascular disease
Sites / Locations
- Kyung Cheon Lee
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
control
electrically heated circuit
Arm Description
use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy
use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy
Outcomes
Primary Outcome Measures
changes of body temperature
record the changes of esophageal and peripheral body temperature every 15 minutes from base line during shouler arthroscopy
Secondary Outcome Measures
Full Information
NCT ID
NCT01493700
First Posted
December 8, 2011
Last Updated
June 26, 2013
Sponsor
Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01493700
Brief Title
Changes of Body Temperature During Shoulder Arthroscopy
Official Title
Effect of Heated Humidifier on the Body Temperature During Shouler Arthroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the effect of electrically heated humidifier on the body temperature during shoulder arthroscopy.
Detailed Description
On the control group, use only routine anesthetic respiratory circuit for mechanical ventilation On the comparative group, use electrically heated humidifier for mechanical ventilation And compared the changes of body temperature durgin shoulder artheroscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
heated circuit, body temperature
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Experimental
Arm Description
use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy
Arm Title
electrically heated circuit
Arm Type
Active Comparator
Arm Description
use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy
Intervention Type
Procedure
Intervention Name(s)
heated circuit
Other Intervention Name(s)
heat circuit
Intervention Description
use electrically heated respiratory circuit (set at 37oC)during mechanical ventilation of anesthetic machine during shoulder arthroscopy
Intervention Type
Procedure
Intervention Name(s)
control
Intervention Description
use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy
Primary Outcome Measure Information:
Title
changes of body temperature
Description
record the changes of esophageal and peripheral body temperature every 15 minutes from base line during shouler arthroscopy
Time Frame
every 15 minutes from base line
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American society of anesthesiologist physical status 1 or 2
20-60 years old
Exclusion Criteria:
body mass index over 30 kg/m2
peripheral vascular disease
uncontrolled cardiovascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Cheon Lee, MD.PhD
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Kyung Cheon Lee
City
Incheon
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
21927679
Citation
Lee HK, Jang YH, Choi KW, Lee JH. The effect of electrically heated humidifier on the body temperature and blood loss in spinal surgery under general anesthesia. Korean J Anesthesiol. 2011 Aug;61(2):112-6. doi: 10.4097/kjae.2011.61.2.112. Epub 2011 Aug 23.
Results Reference
result
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Changes of Body Temperature During Shoulder Arthroscopy
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