Clinical Validation of a Smart Wearable Device to Monitor Cardiac and Respiratory Vital Signs using Morphic Band Sensors ASPEN Trial”

Not Applicable

• Conditions: Cardiac Vital Sign; Respiratory Vital Signs; Cardiovascular - Other cardiovascular diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12621000028808
• Lead Sponsor: Medical Monitoring Solutions Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-14
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1.Healthy Volunteers must have given written informed consent before any study related activities are carried out and must be able to understand the full nature and purpose of the trial including possible risks. Ventilated participants will not be consented however patient’s Person Responsible will be informed of the study and asked to provide consent.
2.Female participants of childbearing potential must not be pregnant or nursing at the time of enrolment.
3.Must be able to be fitted with the device.
4.Provision of use of a Smart phone for the duration of the study, and willingness to download the App for at-home study.
5. If a Healthy participants who consent to the at-home study must be willing to use personal WIFI for App use and phone which has Bluetooth.
6.If in ICU arm admitted for ventilatory support using invasive ventilation as part of standard of care.

Exclusion Criteria

1.Known skin sensitivities or allergies to elasticated products.
2.Broken skin or rashes on torso (where devices will be in contact with the skin).
3.Participant who, in the opinion of the investigator, is not a good candidate for the study.
4.Cardiac pacemaker or implantable defibrillator, known to require defibrillation.
5.Any medical intervention that would interfere with the study.
6.Participant with surgical wounds/dressing precluding the appropriate placement of the investigational device.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory rate (RR) breaths per minute from investigational device compared to gold standard output.[Day 1 and Day 14.];Temperature (skin) in degrees Celsius from investigational device compared to gold standard output.[Day 1 and Day 14.];Heart Rate (HR) beats per minute from investigational device compared to gold standard output.[Day 1 and Day 14.]