Tele-Stroke: Prehospital Identification of Patients With Suspected Stroke Using Onsite Mobile Telemedicine - Feasibility

Study Overview
=================
Brief Summary
-----------------
Observational Study to investigate the technical feasibility, implementation into current diagnostic and treatment pathways and the diagnostic accuracy of the remote patient assessment by using mobile telecommunication ahead of hospitalization.

Detailed Description
-----------------
On-site, pre-hospital clinical assessment of patients with suspected acute stroke can accelerate further diagnostic and treatment pathways after patient arrival at the emergency room or the dedicated stroke center. Interactive video and audio streaming connecting on-site paramedics to a stroke center based stroke physicians can help to overcome these hurdles. Patient evaluation by simple, pre-defined assessment measures and a standardized questionnaire may enable a pre-hospital decision on the need of expedited diagnostic and treatment procedures after arrival at the dedicated stroke center.

Official Title
-----------------
Prehospital Identification of Patients With Suspected Stroke Using Onsite Mobile Telemedicine

Conditions
-----------------
Stroke, Acute

Intervention / Treatment
-----------------
* Diagnostic Test: Audio-video-streaming of suspected stroke symptoms and signs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient older or equal than 18 years with suspected acute stroke as per the first judgement of the paramedics on-site. written informed consent by the patient, or legal representative (next-of kin) or informed consent by an independent physician not involved in the study Exclusion Criteria: -patients with symptoms not attributable to stroke in the emergency onsite ( observation of epileptic seizure, recent cerebral trauma, prior syncope or comatose state)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with suspected stroke<br>patients with suspected stroke due to paramedic's initial evaluation of face, arm, and speech function will be diagnosed with audio-video-streaming of suspected stroke symptoms and signs | Diagnostic Test: Audio-video-streaming of suspected stroke symptoms and signs<br>* The diagnosis based on the patient evaluation by end-to-end encrypted real-time video will be compared to the gold standard, consisting of an in-person neurological examination by a stroke specialist in patients with suspected acute stroke.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the patient evaluation by remote Audio/video session | The proportion of successfully realized 'telestroke' interviews (=patient has a stroke yes/no) in comparison to final diagnosis by the caring stroke team. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of an automated biometric software | The proportion of correct stroke diagnosis by the automatic biometric assessment compared to the final diagnosis of the caring stroke team. | 12 months |