Paramedic - Norwegian Acute Stroke Prehospital Project (ParaNASPP)

September 23, 2021 updated by: Maren Ranhoff Hov, Oslo University Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Prehospital services - Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: eSTROKE
Diagnostic test: eSTROKE model
The eSTROKE model includes an electronic learning module, a full day course with practical teaching of National Institute of Health Stroke Scale and a mobile application which will be used for communication with in-hospital stroke physician
Other Names:
  • ParaNASPP
Active Comparator: Control
Conventional prehospital care
Other: Control
Conventional prehospital care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive predictive value (PPV) of the ParaNASPP model to identify patients suffering acute stroke.
Time Frame: On discharge from hospital - typically within 7 days.
On discharge from hospital - typically within 7 days.

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients in hospitalized within the first 4 hours after symptom onset
Time Frame: first 4 hours On admission
first 4 hours On admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Norwegian Air Ambulance Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2019

Primary Completion (Actual)

July 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (Actual)

October 24, 2019

Study Record Updates

Last Update Posted (Actual)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/2310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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