Enhancing Prehospital Stroke Diagnosis

NCT ID: NCT06427746

Last Updated: 2024-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-08-31

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard

stroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers

Standard

Intervention Type PROCEDURE

Basic ambulance personnel are trained in the application of the CPSS scale in suspected stroke. The CPSS scale is a tool used to quickly assess stroke severity in pre-hospital settings. It is a three-point scale that takes into account the patient's level of consciousness, facial droop, and arm weakness. If a patient with suspected stroke meets certain criteria, they will be coded as having a suspected stroke by the SOREU. These criteria include having one item in three of the CPSS scale, being of adult age, and being independent at home.

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

Video call

Intervention Type PROCEDURE

Among the tools already available to improve evaluation of patients rescued in the field, SOREU has video calls between the dispatch room physician and the rescuer in the field. Thus, the rescuer in the field will perform the CPSS during ongoing video call with the dispatch room, allowing the remote evaluation of the patient by the healthcare worker present in the control room, potentially increasing the ability to identify a stroke.

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 + LARIO

Intervention Type PROCEDURE

LARIO scale's effectiveness in identifying patients with ischemic stroke caused by a large vessel occlusion in the anterior cerebral circulation. The anterior cerebral circulation supplies blood to the front and upper parts of the brain. Occlusion of a large vessel in this area can lead to a severe stroke. Rescuer in the field will perform the CPSS and the LARIO during ongoing video call with the dispatch room, allowing the remote evaluation of the patient by the healthcare worker present in the control room.

Interventions

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Standard

Basic ambulance personnel are trained in the application of the CPSS scale in suspected stroke. The CPSS scale is a tool used to quickly assess stroke severity in pre-hospital settings. It is a three-point scale that takes into account the patient's level of consciousness, facial droop, and arm weakness. If a patient with suspected stroke meets certain criteria, they will be coded as having a suspected stroke by the SOREU. These criteria include having one item in three of the CPSS scale, being of adult age, and being independent at home.

Intervention Type PROCEDURE

Video call

Among the tools already available to improve evaluation of patients rescued in the field, SOREU has video calls between the dispatch room physician and the rescuer in the field. Thus, the rescuer in the field will perform the CPSS during ongoing video call with the dispatch room, allowing the remote evaluation of the patient by the healthcare worker present in the control room, potentially increasing the ability to identify a stroke.

Intervention Type PROCEDURE

Video call + LARIO

LARIO scale's effectiveness in identifying patients with ischemic stroke caused by a large vessel occlusion in the anterior cerebral circulation. The anterior cerebral circulation supplies blood to the front and upper parts of the brain. Occlusion of a large vessel in this area can lead to a severe stroke. Rescuer in the field will perform the CPSS and the LARIO during ongoing video call with the dispatch room, allowing the remote evaluation of the patient by the healthcare worker present in the control room.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agenzia Regionale emergenza Urgenza

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Coppo, MD

Role: PRINCIPAL_INVESTIGATOR

AREU

Locations

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SOREU Metropolitana

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Anna Coppo, MD

Role: CONTACT

0267129001

Giuseppe Ristagno, MD, PhD

Role: CONTACT

0267129001

Facility Contacts

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Paola Manzoni, MD

Role: primary

02 52872802

Other Identifiers

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AREU_A.I.P.O.

Identifier Type: -

Identifier Source: org_study_id

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