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Telestroke 2: Prehospital Triage of Patients With Suspected Stroke Using Onsite Mobile Telemedicine (Telestroke 2)

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ClinicalTrials.gov Identifier: NCT04578002
Recruitment Status : Not yet recruiting
First Posted : October 8, 2020
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:
This study is to investigate clinical efficacy of the pre-hospital triage of patients with suspected acute stroke by using advanced telecommunication tools with digital audio and video real-time streaming.

Condition or disease Intervention/treatment
Stroke, Acute Other: prehospital telemedical triage

Detailed Description:
One of today's main challenges in stroke medicine is to further decrease event-to-treatment-time. On-site, pre-hospital, clinical assessment of patients with suspected acute stroke can optimize further diagnostic and treatment pathways after patient arrival at the dedicated stroke center. A telemedical approach (interactive video and audio streaming) allows time efficient pre-hospital triage, via patient evaluation by simple, pre-defined assessment measures and a standardized questionnaire. This study is to investigate clinical efficacy of the pre-hospital triage of patients with suspected acute stroke by using advanced telecommunication tools with digital audio and video real-time streaming.
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Telestroke 2: Prehospital Triage of Patients With Suspected Stroke Using Onsite Mobile Telemedicine- Efficacy Study
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth

Groups and Cohorts
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Intervention Details:
  • Other: prehospital telemedical triage
    Prehospital Triage of Patients with Suspected Stroke Using Onsite Mobile Telemedicine approach (interactive video and audio streaming). In patients with suspected stroke, a prehospital patient evaluation by end-to-end encrypted real-time audio- and video streaming from the pre-hospital setting to an in-hospital stroke physician, located at the University hospital of Basel, is requested and initiated (telestroke-path). The process is supervised and evaluated by an in-hospital stroke physician in real-time. Patients considered having an acute stroke will be directly transferred to cerebral imaging via CT.

Outcome Measures
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Primary Outcome Measures :
  1. Door-to-treatment-time (minutes) [ Time Frame: one point assessment at baseline ]
    Door-to-treatment-time (minutes), assessed as door-to-needle-time and door-to-groin-puncture-time.


Secondary Outcome Measures :
  1. National Institutes of Health Stroke Scale (NIHSS) at 24hours [ Time Frame: one point assessment at 24hours after hospital admission ]
    Score to quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

  2. National Institutes of Health Stroke Scale (NIHSS) at 90 days [ Time Frame: one point assessment at 90 days after hospital admission ]
    Score to quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

  3. modified Rankin Scale (mRS) at 90 days [ Time Frame: one point assessment at 90 days after hospital admission ]
    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any patient aged ≥ 18 years with suspected acute stroke as per the first judgement of the paramedics on-site at the University hospital of Basel.
Criteria

Inclusion Criteria:

  • 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 a known history of epilepsia or non-epileptic seizures
  • Patients after/while displaying an epileptic seizure
  • Recent head trauma
  • Patient with a reduced Glasgow Coma Scale
Contacts and Locations
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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): NCT04578002


Contacts
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Contact: Philippe Lyrer, Prof. Dr. med. +41 61 265 4435 philippe.lyrer@usb.ch
Contact: Sebastian Thilemann, Dr. med. sebastian.thilemann@usb.ch

Locations
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Switzerland
Stroke Center, Neurology, University Hospital Basel
Basel, Switzerland, 4031
Contact: Philippe Lyrer, Prof. Dr. med.    +41 (0) 61 265 4435    philippe.lyrer@usb.ch   
Contact: Sebastian Thilemann, Dr. med.    +41 61 32 85307    sebastian.thilemann@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Philippe Lyrer, Prof. Dr. med. Stroke Center, Neurology, University Hospital Basel
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04578002    
Other Study ID Numbers: me20Lyrer
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
pre-hospital triage
Stroke, suspected
Telemedicine
telemedical triage
Door-to-treatment-time
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases