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

Completed

• Conditions: Stroke, Acute; COVID-19
• Interventions: Device: MindRhythm Harmony

• Registration Number: NCT04445493
• Lead Sponsor: MindRhythm, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Study Start: 2021-03-01
• Status Verified: 2022-11
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 486

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device: MindRhythm Harmony	MindRhythm Harmony	Passive recording of the head pulse

Primary Outcome Measures

Name	Time	Method
Quality head pulse recordings	Through Study Completion, an average 6 months	Proportion of head pulse studies deemed of high quality for further analysis
Prevalence of COVID-19 infection in suspected stroke population	Through Study Completion, an average of 6 months

Trial Locations

Locations (1)

Wayne State University; 🇺🇸 Detroit, Michigan, United States