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

Stroke, Acute Clinical Trial

— Telestroke 2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04578002
• Other study ID #: 2022-0126; me20Lyrer
• Status: Recruiting
• Start date: November 14, 2022
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Philippe Lyrer, Prof. Dr. med.
• Phone: +41 61 265 4435
• Email: philippe.lyrer[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

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. All other patients will follow conventional stroke path.

Locations

Country	Name	City	State
Switzerland	Stroke Center, Neurology, University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	propatient Forschungsstiftung

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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