Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
230 participants
INTERVENTIONAL
2014-04-30
2015-12-31
Brief Summary
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Accuracy Hypothesis:
The assessment of blood glucose level that results from the OptiScanner is comparable to the YSI 2300 STAT Plus™ Glucose and Lactate Analyzer ("YSI Analyzer"; YSI Life Sciences, Yellow Springs, OH).
Safety Hypothesis:
The OptiScanner has an acceptable risk/benefit profile for a system that can provide repeated automated blood glucose levels for critically ill subjects.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Optiscanner values vs YSI
Matched samples up to 12 times per 24 hour period
The OptiScanner
treatment of blood glucose per standard of care
YSI 2300 STAT Plus™
Interventions
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The OptiScanner
treatment of blood glucose per standard of care
YSI 2300 STAT Plus™
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 18 years old
* Admitted to the ICU or CCU
* Expected ICU or CCU stay of at least 18 hours at the time of enrollment (as judged by Investigator)
* Requires blood glucose monitoring; and
* A vascular access device that can be dedicated for connection to the OptiScanner is either already in-place, is planned to be placed for another purpose or can, in the opinion of the Investigator be safely placed exclusively for use in this study, and another access device is in place or can be placed for manually drawing samples to be evaluated using the YSI Analyzer. Note that CVCs should not be placed solely for the purposes of conducting this study. Refer to section 1.2.7 for details regarding vascular access devices and guidelines for selection and placement.
Exclusion Criteria
* In the Investigator's opinion the subject cannot safely tolerate the amount of saline required to be given to the subject (up to 360 mL per day)
* Hematocrit less than 15% or greater than 60%
* Subjects that require placement of an additional vascular access line will be excluded if they do not have a suitable access site free from any of the following conditions:
* Peripheral vascular disease
* History of placement site neuropathy or chronic pain
* History of placement extremity coagulopathy or clot formation
* History of vascular surgery on the same extremity as catheter placement
* Any medical condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study, including but not limited to a high risk of complications associated with vascular access; or
* Participation in any other investigational drug or device study in the last 30 days and/or while enrolled in this study.
18 Years
ALL
No
Sponsors
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OptiScan Biomedical Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Grant V Bochicchio, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Stanley A Nasraway, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Anthony Furnary, MD
Role: PRINCIPAL_INVESTIGATOR
Providence St. Vincents Medical Center
Linda Moore, MD
Role: PRINCIPAL_INVESTIGATOR
Hermann Memorial Hospital
Locations
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Tufts Medical Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Providence Heart and Vascular Institute
Portland, Oregon, United States
Hermann Memorial Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Nohra E, Buckman S, Bochicchio K, Chamieh J, Reese S, Merrill C, Schuerer D, Bochicchio GV. Results of a near continuous glucose monitoring technology in surgical intensive care and trauma. Contemp Clin Trials. 2016 Sep;50:1-4. doi: 10.1016/j.cct.2016.07.007. Epub 2016 Jul 6.
Other Identifiers
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2002055
Identifier Type: -
Identifier Source: org_study_id
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