EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic ( EPISODEPSCOVID ) (EPISODE-PH-COV)

M

MindRhythm

Status

Completed

Conditions

COVID-19
Stroke, Acute

Treatments

Device: MindRhythm Harmony

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04445493
EPISODE-PH-COVID

Details and patient eligibility

About

Prehospital providers encounter patients with suspected stroke frequently. Stroke and COVID-19 are related potentially putting these healthcare workers at risk of COVID-19 infection. In addition, prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers.

Full description

This observational prospective study will document COVID-19 status on patients seen in the prehospital environment for suspected stroke. This will provide an estimate of how frequently stroke occurs in stroke and also the exposure risk to providers in this setting. Additionally, patients will have a headset placed to record their headpulse during the encounter. These measurements will be used to further develop an analytic model used to predict the presence of large vessel occlusion (LVO) stroke. This may help create a device that can be used in the prehospital environment to aid in the trade decision of destination hospital.

Enrollment

486 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • suspected stroke in the prehospital setting
  • patient at risk for COVID-19

Exclusion criteria

  • scalp laceration
  • Patient refusal
  • Prisoner, other vulnerable population
  • Prehospital provider feels that the recording may interfere with care

Trial design

486 participants in 1 patient group

Device: MindRhythm Harmony
Description:
Passive recording of the head pulse
Treatment:
Device: MindRhythm Harmony

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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