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

Recruiting

• Conditions: Stroke, Acute

• Registration Number: NCT04578002
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

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 Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-08
• Study Start: 2022-11-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05
• Primary Completion: 2024-07
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Door-to-treatment-time (minutes)	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

Name	Time	Method
National Institutes of Health Stroke Scale (NIHSS) at 24hours	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.
modified Rankin Scale (mRS) at 90 days	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).
National Institutes of Health Stroke Scale (NIHSS) at 90 days	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.

Trial Locations

Locations (1)

Stroke Center, Neurology, University Hospital Basel; 🇨🇭 Basel, Switzerland