Smartphone-App Based Prediction of Large Vessel Occlusion

Acute Stroke Clinical Trial

Official title:

Smartphone-App Based Prediction of Large Vessel Occlusion in Suspected Stroke by Emergency Medical Service Using FAST-ED

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04404504
• Other study ID #: 18-8162
• Status: Completed
• Start date: March 20, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2022
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this non-interventional study is to evaluate a German version of the triage stroke-score FAST-ED performed by ambulance service personnel in a pre-hospital setting using a smartphone app (Join-Triage, Allm).

Description:

The emergency service of the city of Essen (NRW, Germany), which is organised by the Essen fire-department, will perform a prehospital triage stroke-score using a smartphone-app (Join-Triage, Allm) when referring patients with suspected stroke to the university clinic Essen. The triage stroke-score FAST-ED (Field Assessment Stroke Triage for Emergency Destination), as well as the expected time of arrival will be transmitted by an additional smartphone-app in advance of the arrival (Join, Allm). Patients will receive emergency workup to identify stroke etiology and presence of large vessel occlusion. Final diagnosis, presence of large vessel occlusion and type of revascularisation treatment will be registered. Sensitivity, specificity and further criteria for test quality will be calculated for the stroke triage by emergency service in field using the FAST-ED.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 30, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

All patients above the age of 18 with suspected acute stroke transferred to the university hospital Essen. Inclusion criteria: suspected acute stroke, age above 18 years and a digitally transmitted FAST-ED by EMS prior to admission. Exclusion criteria: Known symptom onset beyond 24 Hours.

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Locations

Country	Name	City	State
Germany	University Hospital, Essen	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Frank B, Lembeck T, Toppe N, Brune B, Bozkurt B, Deuschl C, Nogueira RG, Dudda M, Risse J, Kill C, Forsting M, Kleinschnitz C, Köhrmann M. FAST-ED scale smartphone app-based prediction of large vessel occlusion in suspected stroke by emergency medical ser — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of large vessel occlusion	Acute stroke due to large vessel occlusion as measured by computed tomography angiography (CT-A)	Baseline