Implementation of Finnish Prehospital Stroke Scale to Emergency Medical Services

Recognition of Thrombectomy Candidate Clinical Trial

Official title:

Implementation of Finnish Prehospital Stroke Scale (FPSS) to Emergency Medical Services - a Prospective, Multi-centre Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03520335
• Other study ID #: R18010
• Status: Recruiting
• Start date: April 24, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2020
• Source: Tampere University Hospital
• Contact: Satu-Liisa K Pauniaho, MD, PhD
• Phone: +358505386783
• Email: satu-liisa.pauniaho[@]pshp.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators have developed a simple prehospital stroke scale (FPSS), containing 5 dichotomized items to recognize both large and small artery thrombi of the brain. FPSS is implemented to both emergency medical services and later, to emergency response centers. The efficacy of the scale and possible improvement of both the patient flow and treatment results will be evaluated.

Description:

Finnish Prehospital Stroke Scale, FPSS, was developed for prehospital setting for prediction of large vessel occlusions (LVOs) and stroke in common. It contains four stroke signs used universally in emergency medical services (EMSs) and emergency response centers (ERCs): 1) facial weakness, 2) extremity weakness, 3) speech disturbance, 4) visual disturbance. Additionally, it contains only one item 5) conjugated gaze deviation, while all the items are presented in dichotomized form. In an earlier, retrospective cohort of 856 code stroke patients, the sensitivity of FPSS for LVOs was highest for thrombi of areas with the documented cost effectiveness of endovascular treatment: internal carotid artery (ICA) and M1 segment of middle cerebral artery (72 % and 82 %). The overall specificity of FPSS for the LVOs was 91 %. For its simplicity it is easy to implement in EMS and ERC as a single score predicting both thrombolysis and thrombectomy candidates.

In the present study accuracy of FPSS will be studied prospectively. FPSS is launched 5/18 in EMS in an area with a population of more than a million, containing districts of five central hospitals capable for thrombolysis and one university hospital capable for endovascular treatment. During 2019-20 FPSS will be launched in two ERCs triaging stroke patients in the study area.

The hypotheses that are tested are:

1. FPSS is accurate to detect ICA and M1 thrombi in EMS setting

2. The use of FPSS shortens door-in-door-out (DIDO) delay patients arriving to central hospitals and redirected to university hospital for thrombectomy.

3. The use of FPSS aids to triage LVO-patients straight to a center capable for thrombectomy

4. FPSS is accurate in the detection of ICA and M1 thrombi in ERC setting

5. The effect of fluent triage of LVO is seen in overall shortened recanalization delay and better outcomes as lower modified Rankin Scores (mRS) in 3 months control compared recanalization delays and 3 month mRS during the pre-implementation period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Acute ischaemic stroke

• Prehospital susipicion of large vessel occlusion

Exclusion Criteria:

• Stroke mimic

Related Conditions & MeSH terms

• Emergencies
• Recognition of Thrombectomy Candidate
• Stroke

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (6)

Lead Sponsor	Collaborator
Tampere University Hospital	Central Finland Hospital District, PaijatHame Central Hospital, Satakunta Central Hospital, Seinajoki Central Hospital, Vaasa Central Hospital, Vaasa, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy	Accuracy of Finnish Prehospital Stroke Scale used in prehospital settingto detect a large vessel occlusion; Finnish Prehospital Stroke Scale (FPSS) includes the following items: Facial droop 0-1, Weakness of one or more extremities 0-1, Difficulty of understand or produce speech, including slurring 0-1, Field cut of visus or blindness 0-1, Partial or fixed gaze or head deviation away from the paretic side 0 or 4. Total points 1-4 predicts non-LVO, = 5 predicts LVO 0-8 (non-LVO= small or medium-sized vessel occlusion; iv-thrombolysis candidate; LVO= large vessel occlusion; endovascular treatment candidate)	3 years
Secondary	90 day survival	90 day survival	3 years
Secondary	90 day modified Rankin score	90 day modified Rankin score	3 years
Secondary	Onset to treatment time	Onset to treatment time	3 years