Stroke Cincinnati Prehospital Stroke Severity Scale Evaluation iN prEhospital (SCENE)

November 18, 2022 updated by: Hospices Civils de Lyon

Evaluation of the Performances of the Cincinnati Prehospital Stroke Severity Scale Realized During Telephone Call With Emergency Department Physicians to Predict Large-vessel Occlusion

The effectiveness of acute ischemic stroke (AIS) management has improved considerably in recent years with thrombolysis and more recently with mechanical thrombectomy (MT). Currently, mechanical thrombectomy can only be performed in stroke unit with an interventional neuroradiology center by experienced/qualified interventional neuroradiologists. In the Rhone area, only one hospital has the authorization to perform mechanical thrombectomy. Therefore, transferring directly eligible acute ischemic stroke patients for mechanical thrombectomy to this center constitutes an important stake of the triage of suspected acute ischemic stroke patients. Some validated scores for the identification of severe strokes and large vessel occlusion, including the Cincinnati prehospital stroke severity scale (CPSSS), appear to be relevant for pre-hospital use in order to identify patients potentially eligible for mechanical thrombectomy and address them to a stoke unit with interventional radiology center.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1272

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bron, France
        • Neurologie, Hôpital Neurologique - HCL
      • Lyon, France, 69003
        • SAMU 69 , Hôpital Edouard Herriot
      • Lyon, France
        • Médecine d'urgence, Clinique de la Sauvegarde
      • Lyon, France
        • Médecine d'urgence, Hôpital de la Croix-Rousse - HCL
      • Lyon, France
        • Médecine d'urgence, Hôpital Desgenettes
      • Lyon, France
        • Médecine d'urgence, Hôpital Mutualiste Médipôle
      • Lyon, France
        • Médecine d'urgence, Hôpital Saint Joseph Saint Luc
      • Pierre-Bénite, France
        • Urgentiste, Centre Hospitalier Lyon Sud
      • Roanne, France
        • Médecine d'urgence, CH de Roanne
      • Tarare, France
        • Médecine d'urgence, Hôpital Nord-Ouest
      • Vienne, France
        • Services Médecine d'urgence et Neurologie, CH de Vienne
      • Villefranche-sur-Saône, France
        • Services Neurologie et Médecine d'urgence, CH de Villefranche sur Saône

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with stroke of the Rhone area after emergency medical services call

Description

Inclusion Criteria:

  • Consecutive patients calling emergency medical services for suspected acute ischemic stroke

Exclusion Criteria:

  • Symptom onset (or the last time the patient was seen without deficit ) of more than 6 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with suspected ischemic stroke
The cohort will be constituted of patients treated for a stroke suspicion after calling emergency medical services of the Rhone and presenting a symptom-onset (the last time the patient was seen without deficit) less than 6 hours.

Tests from Cincinnati prehospital stroke severity scale (CPSSS) will be carried out by the physician at emergency medical services on telephone call with firemen, paramedics or the emergency medical services team for any stroke suspicion that meets the criteria for inclusion. Emergency department physician will have to follow a standardized questionnaire to complete the different items of the score. The score will not be calculated by emergency department physician and will not influence the orientation and management of patients.

The final diagnosis will be the presence or absence of a large vessel occlusion. This diagnosis will be done on cerebral imaging by a neurologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performances of Cincinnati prehospital stroke severity scale
Time Frame: 1 day

The Cincinnati prehospital stroke severity scale is composed of 3 items: 2 points if the patient has a deviation of the gaze, 1 point if the patient is not able to give the date and answer to a simple order such as closing the eyes or clenching the fist and 1 point if the patient presents a hemiplegia. The CPSSS score ranges from 0 to 4, highest value indicating the worst score. It will be considered positive if it is equal to 2 or more.

Performances will be evaluated in terms of sensitivity, specificity, positive and negative predictive values.

1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2018

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

June 7, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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