Visio-conference for Pre-hospital Triage of Stroke Suspicions (OPTIC-AVC)
Primary Purpose
Stroke, Stroke, Acute, Stroke, Ischemic
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Visio conference device evaluation (DVCM)
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke focused on measuring Stroke, Mechanical thrombectomy, Tele-evaluation, Emergency medical service, Pre hospital
Eligibility Criteria
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
Sites / Locations
- CHU de Bordeaux
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Visio conference device evaluation
Arm Description
Neurological tele-evaluation by a neurologist
Outcomes
Primary Outcome Measures
Final effective therapeutic decision
Thrombolysis and/or thrombectomy : yes/no
Secondary Outcome Measures
Therapeutic conviction
Theoretical conviction using Likert scales between the neurologist at the patient bedside and the neurologist using the device for tele-evaluation
Remote evaluation failure
Remote evaluation failure rate
Theoretical therapeutic decision
Theoretical therapeutic decision of the algorithm : thrombolysis and/or thrombectomy [yes/no]
Full Information
NCT ID
NCT04042584
First Posted
July 31, 2019
Last Updated
March 30, 2022
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT04042584
Brief Title
Visio-conference for Pre-hospital Triage of Stroke Suspicions
Acronym
OPTIC-AVC
Official Title
Pre-hospital Optimization of Triage of Stroke Suspicions: Bringing an Embedded Visio Conference Device
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
December 9, 2021 (Actual)
Study Completion Date
December 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Acute, Stroke, Ischemic, Cerebrovascular Disorders
Keywords
Stroke, Mechanical thrombectomy, Tele-evaluation, Emergency medical service, Pre hospital
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Visio conference device evaluation
Arm Type
Experimental
Arm Description
Neurological tele-evaluation by a neurologist
Intervention Type
Procedure
Intervention Name(s)
Visio conference device evaluation (DVCM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Final effective therapeutic decision
Description
Thrombolysis and/or thrombectomy : yes/no
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Therapeutic conviction
Description
Theoretical conviction using Likert scales between the neurologist at the patient bedside and the neurologist using the device for tele-evaluation
Time Frame
Day 0
Title
Remote evaluation failure
Description
Remote evaluation failure rate
Time Frame
Day 0
Title
Theoretical therapeutic decision
Description
Theoretical therapeutic decision of the algorithm : thrombolysis and/or thrombectomy [yes/no]
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33 076
Country
France
12. IPD Sharing Statement
Learn more about this trial
Visio-conference for Pre-hospital Triage of Stroke Suspicions
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