Enhancing Prehospital Stroke Diagnosis (AIPO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Procedure: Standard; Procedure: Video call; Procedure: Video call + LARIO

• Study Type: Observational
• Enrollment (Estimated): 2197

Contacts and Locations

• Study Contact: Name: Anna Coppo, MD; Phone Number: 0267129001; Email: a.coppo@areu.lombardia.it
• Study Contact Backup: Name: Giuseppe Ristagno, MD, PhD; Phone Number: 0267129001; Email: gristag@gmail.com

Study Locations

• Italy
  • Milan, Italy, 20100
    • Recruiting
    • SOREU Metropolitana
    • Contact: Paola Manzoni, MD; Phone Number: 02 52872802; Email: p.manzoni@areu.lombardia.it
    • Principal Investigator: Michela Generali, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients in the prehospital setting with suspected ischemic stroke rescued by the emergency medical service in the Milan metropolitan area

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard; stroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers	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; 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	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.
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Agenzia Regionale emergenza Urgenza
• Investigators: Principal Investigator: Anna Coppo, MD, AREU

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: stroke; video call
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: AREU_A.I.P.O.

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