Back to resultsSequential Compression Device on Body Temperature
Primary Purpose
Hypothermia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
sequential compression device
elastic stockings
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia focused on measuring core temperature, sequential compression device, total intravenous anesthesia
Eligibility 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
Sites / Locations
- HKwak
- Gachon University Gil Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
sequential compression device
elastic stockings
Arm Description
Apply sequential compression device during the thyroidectomy
Apply elastic stockings during the thyroidectomy
Outcomes
Primary Outcome Measures
Core Body Temperature
Core temperature and arteriovenous shunt in the lower leg was measured using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient.
Secondary Outcome Measures
Full Information
NCT ID
NCT01508052
First Posted
January 9, 2012
Last Updated
April 3, 2014
Sponsor
Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01508052
Brief Title
Sequential Compression Device on Body Temperature
Official Title
The Effects of Sequential Compression Device on Body Temperature During Propofol Anaesthesia: A Comparison With Elastic Stockings
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
core temperature, sequential compression device, total intravenous anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sequential compression device
Arm Type
Active Comparator
Arm Description
Apply sequential compression device during the thyroidectomy
Arm Title
elastic stockings
Arm Type
Experimental
Arm Description
Apply elastic stockings during the thyroidectomy
Intervention Type
Device
Intervention Name(s)
sequential compression device
Other Intervention Name(s)
SCD
Intervention Description
applying sequential compression device during the surgery
Intervention Type
Device
Intervention Name(s)
elastic stockings
Other Intervention Name(s)
ES
Intervention Description
applying elastic stockings during the surgery
Primary Outcome Measure Information:
Title
Core Body Temperature
Description
Core temperature and arteriovenous shunt in the lower leg was measured using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient.
Time Frame
from baseline record core temperature every 15 minutes up to operative end
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Jeong Kwak
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
HKwak
City
Incheon
ZIP/Postal Code
402-080
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
12. IPD Sharing Statement
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Sequential Compression Device on Body Temperature
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