Enhancing Prehospital Stroke Diagnosis
AIPO
Accuracy and Implementation of Diagnostic Ability in Stroke in the Pre-Hospital Setting
1 other identifier
observational
2,197
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 14, 2024
CompletedFirst Posted
Study publicly available on registry
May 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedMay 24, 2024
May 1, 2024
1.7 years
May 14, 2024
May 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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 Arms (3)
Standard
stroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers
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 + 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
Interventions
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.
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.
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.
Eligibility Criteria
Adult patients in the prehospital setting with suspected ischemic stroke rescued by the emergency medical service in the Milan metropolitan area
You may qualify if:
- suspected stroke
- rescued by basic life support vehicle
- consciousness
- informed consent
You may not qualify if:
- age \< 18 years
- rescued by an advanced life support vehicle
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SOREU Metropolitana
Milan, 20100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Coppo, MD
AREU
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2024
First Posted
May 24, 2024
Study Start
November 1, 2022
Primary Completion
June 30, 2024
Study Completion
August 31, 2024
Last Updated
May 24, 2024
Record last verified: 2024-05