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

January 9, 2012
April 3, 2014
December 2011
June 2012   (final data collection date for primary outcome measure)
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.
changes in core body temperature [ Time Frame: from baseline record core temperature every 15 minutes ] [ 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.
Complete list of historical versions of study NCT01508052 on ClinicalTrials.gov Archive Site
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Sequential Compression Device on Body Temperature
The Effects of Sequential Compression Device on Body Temperature During Propofol Anaesthesia: A Comparison With Elastic Stockings

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Hypothermia
  • Device: sequential compression device
    applying sequential compression device during the surgery
    Other Name: SCD
  • Device: elastic stockings
    applying elastic stockings during the surgery
    Other Name: ES
  • Active Comparator: sequential compression device
    Apply sequential compression device during the thyroidectomy
    Intervention: Device: elastic stockings
  • Experimental: elastic stockings
    Apply elastic stockings during the thyroidectomy
    Intervention: Device: sequential compression device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01508052
GIRBA2628
Yes
Hyun Jeong Kwak, Gachon University Gil Medical Center
Gachon University Gil Medical Center
Not Provided
Study Director: Hyun Jeong Kwak Gachon University Gil Hospital
Gachon University Gil Medical Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP