NCT01508052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 5, 2014

Completed
Last Updated

May 5, 2014

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

January 9, 2012

Results QC Date

February 24, 2014

Last Update Submit

April 3, 2014

Conditions

Keywords

core temperaturesequential compression devicetotal intravenous anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

sequential compression device

ACTIVE COMPARATOR

Apply sequential compression device during the thyroidectomy

Device: elastic stockings

elastic stockings

EXPERIMENTAL

Apply elastic stockings during the thyroidectomy

Device: sequential compression device

Interventions

applying sequential compression device during the surgery

Also known as: SCD
elastic stockings

applying elastic stockings during the surgery

Also known as: ES
sequential compression device

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I or II
  • year
  • patient who undergoing elective thyroidectomy

You may not qualify if:

  • coronary occlusive disease
  • peripheral vascular disease
  • BMI \> 30 kg/m2
  • abnormal thyroid function test
  • laparoscopic assisted thyroidectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HKwak

Incheon, 402-080, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Stockings, Compression

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Compression BandagesBandagesEquipment and Supplies

Results Point of Contact

Title
Dr.Kwak
Organization
Gachon University

Study Officials

  • Hyun Jeong Kwak

    Gachon University Gil Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 11, 2012

Study Start

December 1, 2011

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

May 5, 2014

Results First Posted

May 5, 2014

Record last verified: 2014-04

Locations