Enhancing Prehospital Stroke Diagnosis

Recruiting

• Conditions: Stroke
• Interventions: Procedure: Standard; Procedure: Video call + LARIO; Procedure: Video call

• Registration Number: NCT06427746
• Lead Sponsor: Agenzia Regionale emergenza Urgenza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-22
• Last Update Submitted: 2024-05-22
• Study First Posted: 2024-05-24
• Last Update Posted: 2024-05-24
• Primary Completion: 2024-06-30
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2197

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard	Standard	stroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers
Video call + LARIO	Video call + LARIO	stroke diagnosis in the pre-hospital settings, based on the CPSS + LARIO scales assessed by lay rescuers (with specific training on the 2 scales) during live video call with the healthcare personnel in EMS dispatch
Video call	Video call	stroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers during live video call with the healthcare personnel in EMS dispatch

Primary Outcome Measures

Name	Time	Method
Accuracy of prehospital stroke diagnosis	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 Outcome Measures

Name	Time	Method
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	LARIO is a stroke scale is a simple 5-item clinical scale that can be used to predict the presence of large vessel occlusion (LVO) in patients with acute ischemic stroke. A large vessel of the anterior cerebral circulation is defined as occlusion of the intracranial segment of the internal carotid artery, anterior cerebral artery segments A1 and A2, and middle cerebral artery segments M1 and M2. Final diagnosis is based on the cerebral angio CT scan
incidence of hemorrhagic stroke	within 2 hours hospital admission	incidence of hemorrhagic stroke among patients identified as stroke patients. Diagnosis is based on the results of the cerebral CT

Trial Locations

Locations (1)

SOREU Metropolitana; 🇮🇹 Milan, Italy