Sequential Compression Device on Body Temperature

April 3, 2014 updated by: Hyun Jeong Kwak, Gachon University Gil Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of, 402-080
        • HKwak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sequential compression device
Apply sequential compression device during the thyroidectomy
Device: elastic stockings
applying elastic stockings during the surgery
Other Names:
  • ES
Experimental: elastic stockings
Apply elastic stockings during the thyroidectomy
Device: sequential compression device
applying sequential compression device during the surgery
Other Names:
  • SCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core Body Temperature
Time Frame: from baseline record core temperature every 15 minutes up to operative end
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Investigators

  • Study Director: Hyun Jeong Kwak, Gachon University Gil Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 11, 2012

Study Record Updates

Last Update Posted (Estimate)

May 5, 2014

Last Update Submitted That Met QC Criteria

April 3, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIRBA2628

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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