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NCT01493700 Clinical Trial

Changes of Body Temperature During Shoulder Arthroscopy

Hypothermia Clinical Trial

Official title:
Effect of Heated Humidifier on the Body Temperature During Shouler Arthroscopy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01493700
Other study ID # GIRBA 2612
Secondary ID
Status Completed
Phase N/A
First received December 8, 2011
Last updated June 26, 2013
Start date December 2011
Est. completion date November 2012

Study information
Verified date June 2013
Source Gachon University Gil Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the effect of electrically heated humidifier on the body temperature during shoulder arthroscopy.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• heated circuit
use electrically heated respiratory circuit (set at 37oC)during mechanical ventilation of anesthetic machine during shoulder arthroscopy
• control
use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy

Locations
Country Name City State
Korea, Republic of Kyung Cheon Lee Incheon

Sponsors (1)
Lead Sponsor Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary changes of body temperature record the changes of esophageal and peripheral body temperature every 15 minutes from base line during shouler arthroscopy every 15 minutes from base line Yes
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