Text Size

Sequential Compression Device on Body Temperature

This study is currently recruiting participants.
Verified December 2011 by Gachon University Gil Medical Center
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: NA
Last verified: December 2011
History: No changes posted
  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:

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

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

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508052

Contacts
Contact: Hyun Jeong Kwak 82-32-460-3400 hyun615@gilhospital.com

Locations
Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: Hyun Jeong Kwak     82-32-460-3400     hyun615@gilhospital.com    
Principal Investigator: Youn Yi Jo            
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
Last Updated: January 9, 2012
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 May 23, 2013