Implementation of Finnish Prehospital Stroke Scale to Emergency Medical Services
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|ClinicalTrials.gov Identifier: NCT03520335|
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : May 17, 2018
|Condition or disease|
|Recognition of Thrombectomy Candidate|
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:
- FPSS is accurate to detect ICA and M1 thrombi in EMS setting
- The use of FPSS shortens door-in-door-out (DIDO) delay patients arriving to central hospitals and redirected to university hospital for thrombectomy.
- The use of FPSS aids to triage LVO-patients straight to a center capable for thrombectomy
- FPSS is accurate in the detection of ICA and M1 thrombi in ERC setting
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Implementation of Finnish Prehospital Stroke Scale (FPSS) to Emergency Medical Services - a Prospective, Multi-centre Study|
|Actual Study Start Date :||April 24, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
- Accuracy [ Time Frame: 3 years ]
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)
- 90 day survival [ Time Frame: 3 years ]90 day survival
- 90 day modified Rankin score [ Time Frame: 3 years ]90 day modified Rankin score
- Onset to treatment time [ Time Frame: 3 years ]Onset to treatment time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520335
|Contact: Satu-Liisa K Pauniaho, MD, PhDfirstname.lastname@example.org|
|Contact: Jyrki P Ollikainen, MDemail@example.com|
|Tampere University Hospital||Recruiting|
|Contact: Satu-Liisa K Pauniaho, MD, PhD +358505386783 firstname.lastname@example.org|