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| Name | Class |
|---|---|
| Research Foundation Flanders | OTHER |
| Vrije Universiteit Brussel | OTHER |
| Brussels Institute for Research and Innovation (INNOVIRIS) | UNKNOWN |
| King Baudouin Foundation |
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Interventional prospective randomized open blinded end-point (PROBE) single-center clinical trial on the evaluation of the efficacy, safety, feasibility, reliability, and cost-effectiveness of in-ambulance telemedicine for patients with suspicion of acute stroke.
The purpose of PreSSUB II is to evaluate the efficacy, safety, feasibility, reliability and cost-effectiveness of in-ambulance telemedicine during Paramedic Intervention Team transportation of patients with suspicion of acute stroke.
The implementation of expert stroke support in the pre-hospital arena using in-ambulance telemedicine is an innovative approach that opens up new perspectives and allows continuous guidance by a stroke specialist throughout the acute stroke care continuum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard pre-hospital emergency care by the Paramedic Intervention Team, in accordance with their standing operating procedures. | |
| Telemedicine | Experimental | In-ambulance teleconsultation by a stroke expert aiming to support the Paramedic Intervention Team by focusing on patient identification, obtaining homeostasis (optimal control of blood pressure, blood oxygenation, temperature, heart rate and rhythm, glycemia), assessment of the patient's neurological status, stroke diagnosis, hospital notification, and patient selection for specific stroke treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Other | In-ambulance telemedicine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Call-to-brain imaging time | Interval between emergency call and imaging of the brain by computed tomography or magnetic resonance imaging in the hospital. | within 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Medical events during in-ambulance telemedicine | Prevalence of medical events diagnosed and corrected during in-ambulance telemedicine (e.g. blood oxygen desaturation, arterial hypertension, arterial hypotension, hypoglycemia, hyperglycemia, cardiac arrhythmia, decreased level of consciousness, hyperthermia) | within 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality 90 (± 10) days after stroke | upto 100 days |
| Adverse event | In-hospital mortality and any adverse event, in particular known complications of delayed stroke care and thrombolytic therapy (e.g. intracranial hemorrhage, systemic bleeding requiring transfusion, inappropriate use of recanalization therapy) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques De Keyser, MD PhD | Universitair Ziekenhuis Brussel | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Brussels | Brussels Capital | 1090 | Belgium |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| OTHER |
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| Recanalisation therapy |
Proportion of patients with ischemic stroke receiving recanalization therapy (i.e. intravenous thrombolysis, endovascular therapy). |
| upto 8 hours |
| Clinical outcome | Assessment of the functional status | upto 12 months |
| upto 12 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |