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Clinical Trials/NCT06427746
NCT06427746
Recruiting
Not Applicable

Accuracy and Implementation of Diagnostic Ability in Stroke in the Pre-Hospital Setting

Agenzia Regionale emergenza Urgenza1 site in 1 country2,197 target enrollmentNovember 1, 2022
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Agenzia Regionale emergenza Urgenza
Enrollment
2197
Locations
1
Primary Endpoint
Accuracy of prehospital stroke diagnosis
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Current American Heart Association Guidelines recommend that stroke patients be promptly rescued and identified so that the accepting hospital can be alerted and prepared to receive and treat them promptly. It is also recommend that stroke identification be performed using validated and standardized assessment scales. This study aims to analyze the possibility to increase the correct identification of stroke patients after implementation of several new operative procedures by the emergency medical service (EMS) of the metropolitan area of Milan (SOREU). The interventions adopted include:

  1. the evaluation of patients with suspected stroke via video call between the lay rescue personnel and the dispatch healthcare personnel
  2. the training of lay rescue personnel, operating in the metropolitan area, aimed at implementing the application of the Cincinnati Prehospital Stroke Scale (CPSS) scale and to expand the neurological examination with the addiction of the Large ARtery Intracranial Occlusion Stroke Scale (LARIO) in the clinical evaluation.
Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
August 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Agenzia Regionale emergenza Urgenza
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • suspected stroke
  • rescued by basic life support vehicle
  • consciousness
  • informed consent

Exclusion Criteria

  • age \< 18 years
  • rescued by an advanced life support vehicle

Outcomes

Primary Outcomes

Accuracy of prehospital stroke diagnosis

Time Frame: within 2 hours from hospital admission

Evaluate if the use of the video call with or without the assessment of the LARIO scale, between the prehospital lay rescuer and the medical dispatch improve the identification of stroke patients in comparison to the only CPSS scale evaluated by the lay rescuer. The diagnosis accuracy is evaluated by confirmation of stroke at the cerebral angio-CT scan

Secondary Outcomes

  • Accuracy of the Large ARtery Intracranial Occlusion (LARIO) scale to identify a stroke with occlusion of a large vessels(within 2 hours from hospital admission)
  • incidence of hemorrhagic stroke(within 2 hours hospital admission)

Study Sites (1)

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