Health Condition 1: null- Post surgical patients admitted into ICUs and expected to remain in ICU for 2-4 days
Conditions
Interventions
Intervention1: Medical device:
Control Intervention1: laboratory blood glucose analyser:
Control Intervention2: i-STAT 1 Analyser MN:300: Model Number: i-STAT 1 MN:300
Sponsors
GlySure Ltd
JSS Medical Research India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient is admitted to the Intensive Care Unit (ICU) and is expected to remain in the ICU for at least 24 hours. 2. The patient must be able to be catheterised with the selected catheter. 3. The patient is aged 18 or over. 4. The patient or legal representative has given Informed consent in writing.
Exclusion criteria
Exclusion criteria: 1. You are aged under 18. 2. You are pregnant. 3. You have occlusive vascular disease. 4. You have undergone recent prior cannulation at the site chosen for cannulation for the study. 5. You have a history of embolism or thrombosis. 6. You have severe haemorrhagic diathesis. 7. You have presence of local sepsis. 8. You have history of heparin induced thrombocytopenia. 9. You are participating in another study that could affect the outcome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Demonstrate acceptability of performance of system, with attention to precision and bias, as compared with the i-STAT Blood Glucose Analyser 2.Demonstrate that precision and bias is acceptable in either arterial or venous placement. 3.Quantify change in precision and bias over average patientâ??s length of stay in the ICU. 4.Identify potential interferences relating to patient disease states or therapy. 5.To determine which sensor membrane offers optimum results Timepoint: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To determine the system meets the userâ??s needs and in particular its ease of use/handling 2. To determine any specific user instructions necessary. 3. To characterise the type and severity of complications associated with the use of the device and therefore any additional warnings and cautions necessary that have not already been identified.Timepoint: 7 days | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
Care Hospitals
Outcome results
None listed