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

Prehospital Identification of Patients With Suspected Stroke Using Onsite Mobile Telemedicine

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute
• Intervention / Treatment: Diagnostic test: Audio-video-streaming of suspected stroke symptoms and signs

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.

• Study Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: propatient Basel
• Investigators: Principal Investigator: Philippe Lyrer, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PP-16-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No