- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04042584
Visio-conference for Pre-hospital Triage of Stroke Suspicions (OPTIC-AVC)
Pre-hospital Optimization of Triage of Stroke Suspicions: Bringing an Embedded Visio Conference Device
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Bordeaux, Frankrike, 33 076
- CHU de Bordeaux
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Visio conference device evaluation
Neurological tele-evaluation by a neurologist
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Final effective therapeutic decision
Tidsramme: Day 0
|
Thrombolysis and/or thrombectomy : yes/no
|
Day 0
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Therapeutic conviction
Tidsramme: Day 0
|
Theoretical conviction using Likert scales between the neurologist at the patient bedside and the neurologist using the device for tele-evaluation
|
Day 0
|
Remote evaluation failure
Tidsramme: Day 0
|
Remote evaluation failure rate
|
Day 0
|
Theoretical therapeutic decision
Tidsramme: Day 0
|
Theoretical therapeutic decision of the algorithm : thrombolysis and/or thrombectomy [yes/no]
|
Day 0
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CHUBX 2017/42
Legemiddel- og utstyrsinformasjon, studiedokumenter
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