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Clinical Trials/NCT04137874
NCT04137874UnknownNot Applicable

Diagnostics and Triage of Acute Stroke by the National Institute of Stroke Scale (NIHSS) by Paramedics, the ParaNASPP (Paramedic - Norwegian Acute Stroke Prehospital Project) Study

Oslo University Hospital2 sites in 1 country1,300 target enrollmentStarted: June 3, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
1,300
Locations
2
Primary Endpoint
Positive predictive value (PPV) of the ParaNASPP model to identify patients suffering acute stroke.

Study Overview

Brief Summary

The main aim of the study is to show that patients with suspected acute stroke met by the emergency medical service and assessed using the eSTROKE model including prehospital NIHSS and a mobile application will identify a higher number of patients with stroke, than those who receive conventional prehospital care.

Detailed Description

Primary aims:

In patients with suspected stroke

  1. The proportion of patients hospitalized with a suspected acute stroke and discharged with a stroke diagnose is significantly increased using the ParaNASPP model compared with conventional prehospital care
  2. Time from onset to hospitalization is significantly reduced with the ParaNASPP model
  3. The ParaNASPP model identifies patients eligible for direct transportation for comprehensive stroke center

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All patients with suspected acute stroke met by emergency medical services (ambulance and rapid response car)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Positive predictive value (PPV) of the ParaNASPP model to identify patients suffering acute stroke.

Time Frame: On discharge from hospital - typically within 7 days.

Secondary Outcomes

  • Number of patients in hospitalized within the first 4 hours after symptom onset(first 4 hours On admission)

Investigators

Sponsor
Oslo University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maren Ranhoff Hov

Principal Investigator

Oslo University Hospital

Study Sites (2)

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