None listed
Conditions
Brief summary
The purpose of this trial is to test the specificity and sensitivity of two types of sensors, used in the Saiiv device, in detecting AF when compared to ECG. Other vital signs including blood pressure (and related arterial stiffness) as well as mechanical performance of the heart will also be measured and compared with standard measurement techniques.
Interventions
This is a proof-of-concept study of a wearable vital signs monitor and App. The primary objective of the trial is to test the hypothesis that the Saiiv Morphic sensors (singularly or in combination), at various anatomical locations, are able to accurately detect atrial fibrillation and measure blood pressure and vascular stiffness compared to standard measurement techniques.
Vital signs will be measured in 30 participants including 15 with atrial fibrillation and 15 with sinus rhythm. Once cons
This is a proof-of-concept study of a wearable vital signs monitor and App. The primary objective of the trial is to test the hypothesis that the Saiiv Morphic sensors (singularly or in combination), at various anatomical locations, are able to accurately detect atrial fibrillation and measure blood pressure and vascular stiffness compared to standard measurement techniques. Vital signs will be measured in 30 participants including 15 with atrial fibrillation and 15 with sinus rhythm. Once consented, all participants will be monitored over a 15 minute period. The study will occur in the hospital/ward setting and in ICU. Participants will lay supine. For the duration of the study participants will be fitted with a 5 lead ECG, one morphic dot over the heart, one morphic dot on the lower sternum, a central blood pressure monitor on the finger (Finapres) and arterial line to measure blood pressure will be in situ as part of routine standard of care. For 1 minute in a series the participant will have the following fitted to measure vital signs and sounds; a digital stethoscope, echocardiogram, Sphygmocor device (measuring arterial stiffness), morphic dot on writs, morphic dot and band on neck, morphic dot on suprasternal notch and morphic dot on temple.
Sponsors
Medical Monitoring Solutions Pty Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Male or female age equal to or greater than 18 years of age in ICU – 15 patients with atrial fibrillation and 15 in sinus rhythm (may have hypertension or indications of heart failure). • In the opinion of the Principal Investigator is a suitable candidate for the study. • Ability to apply morphic sensors at all locations (heart, suprasternal notch, neck, wrist, lower sternum, and temple).
Exclusion criteria
• Episodes of AF or SR that cannot be documented on ECG. • Participating in con-current clinical trial which has not met its primary endpoint or in the investigators opinion participation in this study could affect the primary endpoint of the concurrent study.
Outcome results
None listed