Visio-conference for Pre-hospital Triage of Stroke Suspicions

Stroke Clinical Trial

— OPTIC-AVC  

Official title:

Pre-hospital Optimization of Triage of Stroke Suspicions: Bringing an Embedded Visio Conference Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042584
• Other study ID #: CHUBX 2017/42
• Status: Completed
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: December 9, 2021

Study information

• Verified date: March 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Interventionnal Study to investigate the accuracy of our clinical based algorithm performed by using a visioconference device to assess the eligibility of acute recanalisation treatment (intraveinous thrombolysis (IVT) and/or mechanical thrombectomie (TM). Clinical identification of type of treatment is needed is pre-hospital triage of these patients.

Description:

The outcome of ischemic stroke (IS) with large artery occlusion (LVO) is related to the volume of infarcted brain witch is related to the delay of arterial recanalisation. IVT is available in multiple stroke units in France but, in case of LVO, the association with TM is needed. The availability of endovascular capable centers is limited to tertiary care hospitals. As a result, pre-hospital identification of these patients is a priority and the optimization of the triage can be done by a clinical algorithm carried out by a neurological tele-evaluation.

OPTIC-AVC is a multi-phase study. This phase is about the evaluation of accuracy of our algorithm performed by a quick and standardized neurological tele-evaluation to predict the eligibility for recanalisation treatment (IVT and/or TM) of patients suspected of acute stroke in the emergency setting. The effective therapeutic decision for each patient, performed by another neurologist, will be blind to the theoretical therapeutic decision resulting from the algorithm.

Theoretical and effective therapeutic decision will be compared a posteriori

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: December 9, 2021
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18

• Suspicion of acute symptomatic stroke whose first symptoms are less than 24 hours old

• Free Consent, informed writing signed by the participant or the person of confidence and the investigator (no later than the day of inclusion and before any examination required by research)

Exclusion Criteria:

• Stupor or coma requiring orotracheal intubation

• Rankin pre stroke > 4

• Severe cognitive impairement

• Contraindication to the realiszation of angiographic imaging

• Participation refusal

• Patient under legal protection

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Ischemic Stroke
• Stroke
• Stroke, Acute
• Stroke, Ischemic

Intervention

Procedure:
• Visio conference device evaluation (DVCM)
Standard neurological tele-evaluation (limited to 15minutes) remotely carried out by a first neurologist via a tablet (DVCM) and an operator. A second neurologist assist at the assessment without intervention next to the patient. Once the remote assessment is complet, the second neurologist ensure the continuation of standard patient care.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final effective therapeutic decision	Thrombolysis and/or thrombectomy : yes/no	Day 0
Secondary	Therapeutic conviction	Theoretical conviction using Likert scales between the neurologist at the patient bedside and the neurologist using the device for tele-evaluation	Day 0
Secondary	Remote evaluation failure	Remote evaluation failure rate	Day 0
Secondary	Theoretical therapeutic decision	Theoretical therapeutic decision of the algorithm : thrombolysis and/or thrombectomy [yes/no]	Day 0