Validation of a High-Quality Low-Cost Open-Source Electrocardiograph

Not Applicable

• Conditions: Electrocardiograph; Open Access; Medical Devices; Low Cost
• Interventions: Device: Medical device validation

• Registration Number: NCT04209062
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

The high price of electrocardiograph (ECG) devices - with most hospital-grade devices costing thousands of dollars - is one of the barriers to access of this vital technology. There is a shortage of ECG devices in underserved areas and the devices available on the market currently are not adequate to solve this problem. Our solution is a low-cost high-quality open-access ECG device. This study intends to validate the study ECG device in human patients by demonstrating equivalence between the study ECG device and a gold standard device.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-23
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25
• Study Start: 2023-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases.

Phase 1:

• Healthy
• > 18 years of age

Phase 2:

• > 18 years of age
• non critical patients presenting to the emergency department (Victoria Hospital and University Hospital) with cardiac complaint

Exclusion Criteria

• < 18 years old
• Unable to consent

Phase 1:

• > 70 years of age
• Previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure)
• current status of non-sinus heart rhythm

Phase 2:

• Critical patients in the ED where consent would inappropriately delay investigations or treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control device	Medical device validation	-
Study device	Medical device validation	-

Primary Outcome Measures

Name	Time	Method
Equivalence of Electrical Signals between 3D printed ECG device and Gold Standard ECG	60 seconds	Comparing electrical signals from ECG electrodes with tested device and gold standard device by collecting the following data from both devices: rate, QR interval, PR interval, QT interval, and rhythm.

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada