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

NCT03370094 | Completed

• 1 other identifier: PP-16-23
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diagnostic accuracy of an automated biometric software

  12 months

Study Arms (1)

patients with suspected stroke

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

Interventions

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.

patients with suspected stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The current phase of the project ("Feasibility") will include patients with suspected acute stroke already admitted to the ER of the University Hospital Basel, and patients with suspected acute stroke and who are referred to the Stroke Center of USB by the paramedics.

You may qualify if:

• 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

You may not qualify if:

• patients with symptoms not attributable to stroke in the emergency onsite ( observation of epileptic seizure, recent cerebral trauma, prior syncope or comatose state)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• propatient Basel: collaborator

Study Sites (1)

University Hospital

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Philippe Lyrer

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 12, 2017
• Study Start: August 23, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)