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

Telestroke 2: Prehospital Triage of Patients With Suspected Stroke Using Onsite Mobile Telemedicine- Efficacy Study

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 Overview

• Status: Recruiting
• Conditions: Stroke, Acute
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 94

Contacts and Locations

• Study Contact: Name: Philippe Lyrer, Prof. Dr. med.; Phone Number: +41 61 265 4435; Email: philippe.lyrer@usb.ch
• Study Contact Backup: Name: Sebastian Thilemann, Dr. med.; Email: sebastian.thilemann@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Stroke Center, Neurology, University Hospital Basel
    • Contact: Philippe Lyrer, Prof. Dr. med.; Phone Number: +41 (0) 61 265 4435; Email: philippe.lyrer@usb.ch
    • Contact: Sebastian Thilemann, Dr. med.; Phone Number: +41 61 32 85307; Email: sebastian.thilemann@usb.ch
    • Principal Investigator: Philippe Lyrer, Prof. Dr. med.
    • Sub-Investigator: Sebastian Thilemann, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

Inclusion Criteria:

• suspected acute stroke as per the first judgement of the paramedics on-site

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 or other condition not allowing Rapid Arterial oCclusion Evaluation (RACE) examination

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Door-to-treatment-time (minutes)	Door-to-treatment-time (minutes), assessed as door-to-needle-time and door-to-groin-puncture-time.	one point assessment at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of Health Stroke Scale (NIHSS) at 24hours	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.	one point assessment at 24hours after hospital admission
National Institutes of Health Stroke Scale (NIHSS) at 90 days	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.	one point assessment at 90 days after hospital admission
modified Rankin Scale (mRS) at 90 days	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).	one point assessment at 90 days after hospital admission

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: propatient Forschungsstiftung
• Investigators: Principal Investigator: Philippe Lyrer, Prof. Dr. med., Stroke Center, Neurology, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Telemedicine; pre-hospital triage; Stroke, suspected; telemedical triage; Door-to-treatment-time
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2022-0126; me20Lyrer

Drug and device information, study documents

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