Enhancing Prehospital Stroke Diagnosis

Stroke Clinical Trial

— AIPO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06427746
• Other study ID #: AREU_A.I.P.O.
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: Agenzia Regionale emergenza Urgenza
• Contact: Anna Coppo, MD
• Phone: 0267129001
• Email: a.coppo[@]areu.lombardia.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2197
• Est. completion date: August 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Italy	SOREU Metropolitana	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Agenzia Regionale emergenza Urgenza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of prehospital stroke diagnosis	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	within 2 hours from hospital admission
Secondary	Accuracy of the Large ARtery Intracranial Occlusion (LARIO) scale to identify a stroke with occlusion of a large vessels	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	within 2 hours from hospital admission
Secondary	incidence of hemorrhagic stroke	incidence of hemorrhagic stroke among patients identified as stroke patients. Diagnosis is based on the results of the cerebral CT	within 2 hours hospital admission