HypothermiaNCT01508052
Sequential Compression Device on Body Temperature
A study testing sequential compression device and elastic stockings in people with Hypothermia, run by Gachon University Gil Medical Center at 2 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hypothermia
- What is being tested?
- sequential compression device and elastic stockings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Dec 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or II
- 20-65 year
- patient who undergoing elective thyroidectomy
Who cannot join
- coronary occlusive disease
- peripheral vascular disease
- BMI > 30 kg/m2
- abnormal thyroid function test
- laparoscopic assisted thyroidectomy
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
HKwak
Incheon, 402-080
Gachon University Gil Medical Center
Incheon
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypothermia
- Being tested
- sequential compression device, elastic stockings
- Keywords
- core temperature, sequential compression device, total intravenous anesthesia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequential compression deviceDevice
Also called SCD
applying sequential compression device during the surgery
elastic stockingsDevice
Also called ES
applying elastic stockings during the surgery
| Study group | Role | What they receive |
|---|---|---|
| sequential compression device | Active comparator | Apply sequential compression device during the thyroidectomy Receives: Device: elastic stockings |
| elastic stockings | Experimental | Apply elastic stockings during the thyroidectomy Receives: Device: sequential compression device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline record core temperature every 15 minutes up to operative end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Jeong Kwak, Gachon University Gil Medical Center
- Investigators
- Hyun Jeong Kwak, Study director, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508052
- Sponsor's protocol ID
- GIRBA2628
- Status last verified
- Apr 2014
- First submitted
- 9 Jan 2012
- Last updated
- 5 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sequential Compression Device on Body Temperature During Propofol Anaesthesia: A Comparison With Elastic Stockings
- ClinicalTrials.gov ID
- NCT01508052
- Acronym / sponsor ID
- GIRBA2628
- Conditions
- Hypothermia
- Keywords
- core temperature, sequential compression device, total intravenous anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Posted 5 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sequential compression device | Active comparator | Device: elastic stockingsApply sequential compression device during the thyroidectomy |
| elastic stockings | Experimental | Device: sequential compression deviceApply elastic stockings during the thyroidectomy |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I or II
- 20-65 year
- patient who undergoing elective thyroidectomy
Key exclusion criteria (5 listed)
- coronary occlusive disease
- peripheral vascular disease
- BMI > 30 kg/m2
- abnormal thyroid function test
- laparoscopic assisted thyroidectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sequential compression deviceAlso: SCDapplying sequential compression device during the surgery | Device | elastic stockings |
| elastic stockingsAlso: ESapplying elastic stockings during the surgery | Device | sequential compression device |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Jeong Kwak study director
Gachon University Gil Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sequential compression device and elastic stockings in people with Hypothermia, run by Gachon University Gil Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Body Temperature (time frame: from baseline record core temperature every 15 minutes up to operative end). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2014.