Ultrasound for Acute Field Triage of Stroke

Acute Ischemic Stroke Clinical Trial

— USTRAFAST  

Official title:

Ultrasound for Acute Field Triage of Stroke: a Pilot Study- Ustrafast

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05845203
• Other study ID #: DR230049- USTRAFAST
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Tours
• Contact: BOULOUIS Grégoire, Dr
• Phone: 02 47 47 47 25
• Email: g.boulouis[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute ischemic stroke (AIS) is responsible for considerable morbidity and mortality worldwide and has serious medico-economic and psychosocial consequences. Before the advent of mechanical thrombectomy (TM), care and telestroke networks had focused their efforts on the rapid administration of a thrombolytic agent, tissue plasminogen activator (tPA), intravenously ( IV), to all eligible patients with ischemic stroke. These care networks have been shown to improve both patient prognosis by improving early vascular recanalization, the overall quality of neurovascular care within the network, and costs at network hospitals.

In 2015, the effectiveness of another treatment, TM, for some acute ischemic stroke patients with large vessel occlusion (LVO) created new challenges for the effective triage of suspected patients stroke, especially in the prehospital setting.Indeed, non-OLV patients should receive intravenous thrombolysis without delay and thus should be transported to the nearest facility with neurological capacity. thrombolysis.In contrast, the efficacy of thrombolysis remains limited for patients with LVO stroke who likely benefit from direct transport from the field to a comprehensive stroke center capable of performing TM. In these patients, stopping at a local center to initiate thrombolysis can delay revascularization and worsen the prognosis.These sorting strategy paradigms, called "mothership" and "drip and ship"

Description:

Investigators hypothesize that the use of a compact DTC system may optimize prehospital triage of participants with suspected stroke by EMS emergency medical services with rapid applicability and limited training required. The objectives of this study will be to:

1. assess the role of cerebral pulsatility index as a marker of proximal vessel occlusion, and its added value to PSV, EDV, RI and MV,

2. optimize the engineering and ergonomics parameters of the DTC mechanical support system,

3. test its speed of application on healthy subjects, then on participants who have suffered a confirmed stroke, and

4. to use this data to derive a fully operational DTC system and a dedicated interface for a larger scale real test in a pre-hospital setting.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 30, 2024
• Est. primary completion date: July 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Healthy subjects (recruitment via the CIC-IC):

• Adults (Age >18),

• free from any known cerebral pathology,

• having given their informed, dated and signed free consent

• and affiliated with a French social security scheme (CMU accepted)

Stroke topics:

• Adult patients (age >18 years),

• admission for suspected stroke with a severity scale assessed by an NIH Stroke Scale > 10 with or without signs of cortical damage.

• Onset of symptoms < 24 hours.

• Proximal arterial occlusion confirmed by angio-MRI or angio-scan,

• free informed consent, dated and signed,

• affiliated to a French social security scheme (CMU accepted).

Exclusion Criteria:

(healthy subjects and patients)

• Realization of the transcranial Doppler likely to delay the treatment of the patient

• Patient eligible for thrombectomy. vs

• Major agitation (+3 on the Richmond Agitation Sedation Scale) (done only when the patient is agitated).

• Inability of the patient to consent due to the severity of the clinical symptoms, and the absence of an available relative.

• History of severe head trauma, or significant deformation of the skull.

• Recent craniofacial trauma with recent scalp or facial wounds.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Diagnostic Test:
• perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere
perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of cerebral pulsatility (maximum and average), peak diastolic and systolic velocity, peak systolic velocity, resistance index and pulsatility	The main outcome is to measure the cerebral pulsatility which will be assessed by all this diiferents measures in the same time such as : Peack diastolic and systoic velocity in cm/sec which will help to determine the resistance index and the pulsatility index at end with the help of the transcranial doppler at letf side and right side. The parameters will be compared at the level of a patient (healthy vs pathological hemisphere), and of the hemispheres (all healthy vs pathological hemispheres).	1 day
Secondary	Patient questionnaire on per-procedure comfort parameters	he secondary outcomes are to evaluate if wearing a support to assesed the pulsatility billateraly might generate some disconfort to the patient. That is why we will use one of the universal scale, the Likert confort to disconfort scale to evaluate disconfort from the great confort imaginale to the great disconfort imaginable of the participants.	1 day