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Completed

NCT Number: NCT03370094

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

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.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Audio-video-streaming of suspected stroke symptoms and signs

Diagnostic Test

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.

Primary outcomes

  1. Diagnostic accuracy of the patient evaluation by remote Audio/video session

    Time frame: 1 hour

    The proportion of successfully realized 'telestroke' interviews (=patient has a stroke yes/no) in comparison to final diagnosis by the caring stroke team.

Secondary outcomes

  1. Diagnostic accuracy of an automated biometric software

    Time frame: 12 months

    The proportion of correct stroke diagnosis by the automatic biometric assessment compared to the final diagnosis of the caring stroke team.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • propatient Basel

Registry information

Official study title

Prehospital Identification of Patients With Suspected Stroke Using Onsite Mobile Telemedicine

Acronym: Tele-Stroke

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2017
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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