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Sequential Compression Device on Body Temperature

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01508052
First Posted: January 11, 2012
Last Update Posted: May 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hyun Jeong Kwak, Gachon University Gil Medical Center
  Purpose
We hypothesized that sequential compression device (SCD) compression system might induce more decreases on core temperature by increasing lower extremity blood flow. And, this study investigated the effects of SCD compression system on body temperature in patients during total intravenous anesthesia (TIVA) with propofol and remifentanil.

Condition Intervention
Hypothermia Device: sequential compression device Device: elastic stockings

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Sequential Compression Device on Body Temperature During Propofol Anaesthesia: A Comparison With Elastic Stockings

Resource links provided by NLM:


Further study details as provided by Hyun Jeong Kwak, Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Core Body Temperature [ Time Frame: from baseline record core temperature every 15 minutes up to operative end ]
    Core temperature and arteriovenous shunt in the lower leg was measured using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient.


Enrollment: 40
Study Start Date: December 2011
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sequential compression device
Apply sequential compression device during the thyroidectomy
Device: elastic stockings
applying elastic stockings during the surgery
Other Name: ES
Experimental: elastic stockings
Apply elastic stockings during the thyroidectomy
Device: sequential compression device
applying sequential compression device during the surgery
Other Name: SCD

Detailed Description:
Anaesthesia was induced and maintained with propofol and remifentanil. During the surgery, temperature was measured and recorded using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient, respectively.
  Eligibility

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I or II
  • 20-65 year
  • patient who undergoing elective thyroidectomy

Exclusion Criteria:

  • coronary occlusive disease
  • peripheral vascular disease
  • BMI > 30 kg/m2
  • abnormal thyroid function test
  • laparoscopic assisted thyroidectomy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508052


Locations
Korea, Republic of
HKwak
Incheon, Korea, Republic of, 402-080
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Study Director: Hyun Jeong Kwak Gachon University Gil Medical Center
  More Information

Responsible Party: Hyun Jeong Kwak, Associate professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01508052     History of Changes
Other Study ID Numbers: GIRBA2628
First Submitted: January 9, 2012
First Posted: January 11, 2012
Results First Submitted: February 24, 2014
Results First Posted: May 5, 2014
Last Update Posted: May 5, 2014
Last Verified: April 2014

Keywords provided by Hyun Jeong Kwak, Gachon University Gil Medical Center:
core temperature
sequential compression device
total intravenous anesthesia

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms