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| Name | Class |
|---|---|
| Probe Scientific Limited | INDUSTRY |
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This study evaluates the validity of an intravascular continuous glucose monitoring microdialysis probe, and compares the values to routinely inserted cerebral glucose microdialysis to evaluate the hypothesised relationship between intracranial and intravascular glucose levels.
All recruited patients will in any case have probes inserted in theatre for brain tissue glucose monitoring as a part of their standard clinical care. Probes will be allowed to stabilize following insertion as is standard clinical practice. A peripheral venous catheter will be inserted by the study team to allow introduction of the intravascular microdialysis probe. This will be attached to a regular infusion pump set at 3ml/hr and normal saline, to produce the microdialysate. The efflux of microdialysate will be connected to the biosensor, and once passed over the biosensor the subsequent dialysate will be destroyed. A risk assessment will be made on the basis of the patient's coagulation status and concurrent venous thromboembolism prophylaxis, and if necessary, low dose low molecular weight heparin will be included in the saline infusion to ameliorate risk of local thrombosis in the device. This has a local effect only and does not produce systemic anticoagulation.
After a brief period of probe stabilisation, 2 ml of blood will be withdrawn for blood gas analysis (including glucose), and the probe readings will be calibrated against this value. Subsequent calibration will take place 6 hours later, and then at 12 hourly intervals. A maximum total of 30ml of blood will be required for each patient for blood oxygen content analysis. Clinically necessitated blood sampling for blood gases will continue, and these values will be collected post-hoc from our E-hospital clinical records system.
Further data will be collected post-hoc via e-Hospital clinical records system, including: routinely recorded measures of cerebral extracellular fluid glucose concentration, physiological parameters (central venous pressure, mean arterial pressure, intracranial pressure etc), timing and detail of interventions as determined appropriate by routine clinical decision making.
The study will terminate at 72 hours, whereupon the device will be detached and the peripheral venous catheter will be removed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitoring with MicroEye & ContinuMon | 72 hour study interval with monitoring using intravascular glucose monitoring system alongside routine clinical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MicroEye & ContinuMon | Device | Continuous intravascular glucose monitoring using MicroEye/ContinuMon system, peripherally inserted via a peripheral venous catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Continuously measured intravascular glucose concentration | Study inserted microdialysis catheter for collection of data on the concentration of glucose in this space. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Intermittently measured intravascular glucose concentration | Routinely collected data on the concentration of glucose in this space at specific time points. | 72 hours |
| Cerebral extracellular fluid glucose concentration |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are admitted to the Neurocritical Care Unit with a severe acquired brain injury
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew R Stevens, MBChB | Contact | +44 7577 301242 | a.stevens@doctors.org.uk | |
| Ari Ercole, PhD | Contact | +44 1223 217 889 | ae105@cam.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Ari Ercole, PhD | Lecturer and Consultant Anaesthetist | Principal Investigator |
| Peter Hutchinson, PhD | NIHR Research Professor at the Department of Clinical Neurosciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D002543 | Cerebral Hemorrhage |
| D013345 | Subarachnoid Hemorrhage |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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Routinely inserted microdialysis catheter for collection of data on the concentration of glucose in this space.
| 72 hours |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |