In the DETECT-2 study, we aim to construct an algorithm for detection of cardiac arrest related falls using wrist-derived accelerometer signals from simulated sudden falls and non-fall movements. The sensitivity and false positive rate of theā¦
ID
Source
Brief title
Condition
- Other condition
- Heart failures
Synonym
Health condition
Detectie van een val
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To construct an algorithm for detection of cardiac arrest related falls using
wrist-derived accelerometer signals from simulated sudden falls and non-fall
movements and study the sensitivity and specificity of the developed algorithm.
Secondary outcome
1. To study wrist-derived accelerometry signal characteristics in relation to
sudden falls, soft falls and non-fall-motions in healthy subjects who simulate
falls.
2. To study positive and negative predictive value of the algorithm for sudden
falls.
3. To study sensitivity and false positives of an algorithm to detect soft
falls.
4. To identify sources of noise interfering with correct accelerometry-based
measurement of movements.
5. To study false positive rates of the recently developed first PPG-based
cardiac arrest detection algorithm (DETECT-1) in this controlled study setting
6. To validate the steps per minute recorded by the CardioWatch by the steps
per minute recorded by the CE/FDA certified Actigraph.
7. To validate the active calories per minute recorded by the CardioWatch by
the active calories per minute recorded by the CE/FDA certified Actigraph.
Background summary
While survival from out-of-hospital cardiac arrest has markedly improved over
the past decade, for victims of unwitnessed cardiac arrest medical assistance
often comes too late. Automated cardiac arrest detection and alarming would be
an ideal solution to provide early help for this large subset. In the DETECT
project, we aim to develop a smartwatch with the functionality of automated
cardiac arrest detection and alarming. The primary sensor technology used to
detect cardiac arrest is photoplethysmography (PPG). This is an
easy-to-understand technology based on reflection of light to detect absence of
pulsatile flow at the wrist. In the DETECT-1 study, a PPG-based algorithm for
cardiac arrest detection is being developed using data from patients with
short-lasting induced circulatory arrests. However, to come to a reliable
cardiac arrest detection algorithm with low false positives, we need to take
into account additional sensor data to confirm or exclude the presence of
circulatory arrest. Accelerometer sensors measure acceleration and provide
information on human movement. Since a first manifestation of cardiac arrest is
sudden physical collapse without subsequent movement, these sensor data may
provide valuable information to exclude or confirm cardiac arrest. For example,
in case a patient continues to walk, this cannot be a cardiac arrest. In case,
a patient collapses and shows no movement, a cardiac arrest is more likely.
Study objective
In the DETECT-2 study, we aim to construct an algorithm for detection of
cardiac arrest related falls using wrist-derived accelerometer signals from
simulated sudden falls and non-fall movements. The sensitivity and false
positive rate of the developed algorithm for sudden fall detection will be
studied. Additionally, collected data of the PPG sensor will be used to study
false positive rates of the recently developed first PPG-based cardiac arrest
detection algorithm (DETECT-1).
Study design
The DETECT-2 is a Dutch prospective simulation study performed in a controlled
setting.
Study burden and risks
In this study, the participants will be asked to simulate falls. Risks
associated with these falls could be bruises, abrasions and in the worst case
more serious injuries, such as fractures. To minimize the risk of injuries, the
study will be performed in a controlled setting on a soft surface and under
supervision of trainer. Furthermore, the included subjects will be healthy to
minimize the risk of injury as well.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Aged between 18 and 40
- Fitting the wristband
Exclusion criteria
- Unwilling or unable to provide informed consent
- Medical issues that interfere with wearing of the wristband (e.g., skin
disorders)
- (Physically) unable or unwilling to perform the (fall-)motions
- Relevant health issues (e.g. osteoporosis)
Design
Recruitment
Medical products/devices used
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In other registers
Register | ID |
---|---|
CCMO | NL82171.091.23 |