Sequential Compression Device on Body Temperature

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyun Jeong Kwak, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01508052
First received: January 9, 2012
Last updated: April 3, 2014
Last verified: April 2014
Results First Received: February 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Hypothermia
Interventions: Device: sequential compression device
Device: elastic stockings

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sequential Compression Device

Apply sequential compression device during the thyroidectomy

elastic stockings: applying elastic stockings during the surgery

Elastic Stockings

Apply elastic stockings during the thyroidectomy

sequential compression device: applying sequential compression device during the surgery


Participant Flow:   Overall Study
    Sequential Compression Device     Elastic Stockings  
STARTED     20     20  
COMPLETED     20     20  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sequential Compression Device

Apply sequential compression device during the thyroidectomy

elastic stockings: applying elastic stockings during the surgery

Elastic Stockings

Apply elastic stockings during the thyroidectomy

sequential compression device: applying sequential compression device during the surgery

Total Total of all reporting groups

Baseline Measures
    Sequential Compression Device     Elastic Stockings     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: years]
Mean ± Standard Deviation
  47.6  ± 9.3     48.2  ± 11.5     48  ± 10  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     20     40  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     20     20     40  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     20     20     40  



  Outcome Measures

1.  Primary:   Core Body Temperature   [ Time Frame: from baseline record core temperature every 15 minutes up to operative end ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr.Kwak
Organization: Gachon University
phone: 82324603400
e-mail: hyun615@gilhospital.com


No publications provided


Responsible Party: Hyun Jeong Kwak, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01508052     History of Changes
Other Study ID Numbers: GIRBA2628
Study First Received: January 9, 2012
Results First Received: February 24, 2014
Last Updated: April 3, 2014
Health Authority: Korea: Institutional Review Board