upBeat® Biosensors are designed for continuous 24x7 monitoring of persons wherever they are at home, office, hospital, etc i.e. both inpatient and outpatient. upBeat® is undergoing rigorous pre-clinical testing to evaluate it's performance and improve it based on the feedback. This article details one such pre-clinical study for outpatient ambulatory monitoring.
What is ambulatory monitoring?
The word "ambulatory" is used to represent patients who are able to walk and are not bedridden. Therefore, ambulatory monitoring refers to monitoring performed on persons at their home, office, and wherever they go.
Ambulatory electrocardiographic (ECG) monitoring is used to help doctors diagnose intermittent cardiac arrhythmias that occur only infrequently and unpredictably. Such arrhythmias often produce sudden symptoms, but typically are no longer present by the time a person gets to a doctor. For this reason, many symptom-producing cardiac arrhythmias are difficult or impossible to diagnose with a standard electrocardiogram.
Ambulatory ECG monitoring can be employed to record your heart rhythm for much longer periods of time—days, weeks, or even years—to greatly increase the odds of capturing and recording this kind of brief, intermittent, but potentially significant arrhythmia.
Why is ambulatory monitoring is far more challenging compared to in hospital monitoring?
In hospitals patients are mostly lying down on bed whether in rooms, intensive care units or operating theaters. There is limited movement of patients within hospitals.
On the other hand, the range of movements increase manifold outside of hospital - walking, sitting, climbing up & down stairs, bending, reaching out for things, exercising, picking up kids, lifting objects, playing sport and more. With each movement, noise is generated in target signals of interest. This noise could be baseline wander, muscle tremor and/or power line interference.
The presence of noise and the ability to decipher signals of interest from noise makes ambulatory monitoring far more challenging than in hospital monitoring.
Monitra's upBeat® Biosensors
upBeat® is a wearable medical grade biosensing skin patch that continuously 24x7 captures electrocardiogram (ECG) and tracks posture as well as activities in real-time. This physiological data is transmitted continuously to the phone and the information is relayed to our cloud platform, upBeat®.AI.
The objective of this pre-clinical study was test the performance of upBeat® biosensors during the range of movements possible in our target user set.
To meet the objective it was decided to simulate movements that could occur during ambulatory monitoring of target user across age, gender & BMI. The protocol consisting of covering the following activities within an hour or two - sitting, lying down, deep-breathing, walking briskly & climbing up & down stairs. In case, any person is unable to complete an activity, they can skip or replace with some other comfortable activity.
Gender, Age & BMI were considered during sampling such that we had representation in each category. Doing so allows us to not just test in broad spectrum of categories but also solicit feedback from each category. We conducted the study on 61 subjects.
Abnormal findings were found in several subjects during this pre-clinical testing. Some are listed below and individual articles have been written on them.
PR interval prolongation - 37 years old female
ST segment depression & T-wave inversion post climbing stairs - 79 year old male
Non-sustained PSVT - 95 years old male
Irregularly irregular rhythm - 71 years old female
Irregularly irregular rhythm - 60 years old male