Sequential Compression Device on Body Temperature

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyun Jeong Kwak, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01508052
First received: January 9, 2012
Last updated: April 3, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01508052

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

No publications provided

Responsible Party: Hyun Jeong Kwak, Associate professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01508052     History of Changes
Other Study ID Numbers: GIRBA2628
Study First Received: January 9, 2012
Results First Received: February 24, 2014
Last Updated: April 3, 2014
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 21, 2014