Changes of Body Temperature During Shoulder Arthroscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Youn Yi Jo, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01493700
First received: December 8, 2011
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Hypothermia
Procedure: heated circuit
Procedure: control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Heated Humidifier on the Body Temperature During Shouler Arthroscopy

Resource links provided by NLM:


Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • changes of body temperature [ Time Frame: every 15 minutes from base line ] [ Designated as safety issue: Yes ]
    record the changes of esophageal and peripheral body temperature every 15 minutes from base line during shouler arthroscopy


Enrollment: 50
Study Start Date: December 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: control
use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy
Procedure: heated circuit
use electrically heated respiratory circuit (set at 37oC)during mechanical ventilation of anesthetic machine during shoulder arthroscopy
Other Name: heat circuit
Active Comparator: electrically heated circuit
use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy
Procedure: control
use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy
Other Name: control

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01493700

Locations
Korea, Republic of
Kyung Cheon Lee
Incheon, Korea, Republic of
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Study Director: Kyung Cheon Lee, MD.PhD Gachon University Gil Medical Center
  More Information

Publications:
Responsible Party: Youn Yi Jo, Asistant professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01493700     History of Changes
Other Study ID Numbers: GIRBA 2612
Study First Received: December 8, 2011
Last Updated: June 26, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Gachon University Gil Medical Center:
heated circuit
body temperature

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014