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NCT01508052 Clinical Trial

Sequential Compression Device on Body Temperature

Hypothermia Clinical Trial

Official title:
The Effects of Sequential Compression Device on Body Temperature During Propofol Anaesthesia: A Comparison With Elastic Stockings

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01508052
Other study ID # GIRBA2628
Secondary ID
Status Completed
Phase N/A
First received January 9, 2012
Last updated April 3, 2014
Start date December 2011
Est. completion date December 2012

Study information
Verified date April 2014
Source Gachon University Gil Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• sequential compression device
applying sequential compression device during the surgery
• elastic stockings
applying elastic stockings during the surgery

Locations
Country Name City State
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of HKwak Incheon

Sponsors (1)
Lead Sponsor Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. from baseline record core temperature every 15 minutes up to operative end No
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