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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370094
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
propatient Basel
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment
Stroke, Acute 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.

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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prehospital Identification of Patients With Suspected Stroke Using Onsite Mobile Telemedicine
Actual Study Start Date : August 23, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370094


Locations
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Switzerland
University Hospital
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
propatient Basel
Investigators
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Principal Investigator: Philippe Lyrer University Hospital, Basel, Switzerland
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03370094    
Other Study ID Numbers: PP-16-23
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases