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Evaluation of Time to detection of Hyperglycemia And of Nursing Ease of use (ETHANE)


Title Evaluation of Time to detection of Hyperglycemia And of Nursing Ease of use (ETHANE) 
Therapeutic Area Heart Diseases
Principal Investigator John Adam Reich, MD
Min Age 18 Years
Gender All
Contact Iwona Bonney
617 636 9322

Overview

The OptiScanner® 5000 Glucose Monitoring System from OptiScan Biomedical Corporation is an automated, bedside glucose monitoring system designed to quantitatively measure the concentration of venous blood glucose. The objective of this study is to evaluate the performance of the OptiScanner 5000 Glucose Monitoring System, a continuous, automated glucose monitor for the Surgical ICU. The OptiScanner 5000 Glucose Monitoring System (OptiScanner) will decrease time spent obtaining glucose values, improve efficiency and increase nursing satisfaction in the Surgical ICU, specifically in administering care to patients who require frequent bedside glucose monitoring. The OptiScanner will allow for earlier detection of hyperglycemia follow cardiac surgeries which require cardiopulmonary bypass by automating glucose measurement collection and displaying trending data. 

Study Details

Inclusion Criteria

  • Signed informed consent by the participant or his/her legally authorized representative
  • At least 18 years old and requires glucose monitoring
  • Surgical ICU patient who has received cardiopulmonary bypass during a surgical procedure and expected overnight Surgical stay in the SICU stay of at least two calendar days at the time of enrollment
  • A vascular access device that can be dedicated for a proximal port connection to the OptiScanner is either already in-place, or is planned to be placed. (i.e., Central Venous Catheters (CVC), Multi-lumen Access Catheters (MAC))

Exclusion Criteria

  • Patient's chest is maintained open with plan to return to OR in less than 24 hours. If plan is to wait > 24 hours before return to OR, it is OK to enroll the patient.
  • Patients who have undergone peritoneal dialysis within the last week or who are anticipated to undergo PD during study. Hct <15%; Positive HcG (serum or urine) in women of childbearing potential who are not known to be surgically sterile and those that are obviously pregnant.
  • Patients receiving intravenous administration of high dose ascorbate (IVC) for the treatment of patients with cancer. Patients following the administration of a D-Xylose absorption test < 12 hours, patients being treated with Sodium Thiosulfate. Patients receiving IV glycerol. Patients receiving substances containing maltose or substances that can be metabolized into maltose. These substances include Extranneal, Gamimune N, HepaGam B, Octagam, Vaccinia Immune Globulin, and WinRho SDF Liquid.

Study Requirements

OptiScanner subjects enrolled in the study will participate for a minimum of 18 and a maximum of 72 hours. The OptiScanner® 5000 Glucose Monitoring System from OptiScan Biomedical Corporation is an automated, bedside glucose monitoring system designed to quantitatively measure the concentration of venous blood glucose. When attached to a patient, the OptiScanner® 5000 Glucose Monitoring System automatically draws a 3 ml blood sample, retains a micro-sample of blood for analysis (0.17 ml), and returns the remaining portion of the blood to the patient. The OptiScanner® 5000 Glucose Monitoring System analyzes the retained portion of the blood sample and then displays a glucose value. The blood glucose will be measured every 15 minutes. The connection between the OptiScanner and the patient is accomplished through a vascular access device. Vascular access devices for OptiScanner connection include Central Venous Catheters (CVC) and Multi-lumen Access Catheters (MAC).