Qualitative and quantitative evaluation of a new wearable device for ECG and respiratory Holter monitoring
Introduction
Cardiorespiratory monitoring is used to assess athletes, normal subjects, and patients with different diseases [1]. It has a pivotal role in patients' management and frequently allows to underscore unexpected clinical conditions or to explain unclear and frightening symptoms [2]. The monitoring is based on two major aspects: a) ECG monitoring and b) respiratory monitoring. Both include day-time and night-time monitoring as well as rest and exercise. ECG monitoring is performed by continuous recording of 1 to 12 ECG leads done for 24 h up to seven days. The recording of ECG traces is usually obtained by electrodes and an external recorder fastened together by cables or by a Wireless technology [3]. In the real world setting, the loss of the signal or poor signal quality is experienced frequently. Respiratory monitoring can detect hypopnea and apnea which is obtained by a nasal flow recorder combined with respiratory movement recorders usually located both at the chest and abdominal level. As for ECG recording, electrodes and cables are required and often lead to failed signal connection and variable signal quality [4, 5].
Learn Inspire Free Entertain (L.I.F.E.) device has been built to simultaneously record ECG and respiratory movement through different sensor elements woven into the fabric of a compressible, self-wearable and washable garment which is even suitable for a residential laundry machine. With a single recording, both ECG Holter and polysomnography data are simultaneously registered with certain advantages. Specifically, apnea/hypopnea induced arrhythmias [[6], [7], [8]] are detectable. In a comprehensive comparability study, several cardiorespiratory monitoring devices have been proposed but none have the characteristics of L.I.F.E. shirt.
The following study was therefore undertaken to assess the overall quality of the ECG and respiratory monitoring by L.I.F.E. shirt. Our assessment, by two independent cardiologists, studies a 24 h period of the quality of the ECG traces as it pertains to heart rate and specific ECG waves in 12 leads. Additionally, five respiratory traces (plus one sum-signal which combines all the respiratory traces) were assessed by two respiratory physiologists in 10 healthy subjects and 30 cardiorespiratory patients. In the healthy volunteers, a comparative analysis between respiratory parameters, assessed by a commercial ergo-spirometer used as gold standard, and L.I.F.E. shirt was performed in different body positions and during different stages of hyperpnea. Simulated obstructive and central apneas were analyzed as well.
Section snippets
Subjects
This is a cross-sectional study performed within the confines of the World Medical Association Declaration of Helsinki. All subjects were recruited from the Centro Cardiologico Monzino (Milan, Italy), from January 2016 to February 2017, and signed an Inform Consent Form. The study was approved by Centro Cardiologico Monzino Ethical Committee (CCM 448). Inclusion criteria were: age 20–80 years and stable clinical conditions. L.I.F.E.
Measurements
L.I.F.E.'s medical compression garment (CE approval n.
Statistical evaluation
All data are expressed as mean ± standard deviation unless otherwise stated. Differences between ventilatory parameters obtained by L.I.F.E. and ergo-spirometer in each maneuver and position were expressed in relative values (i.e. data obtained with L.I.F.E garment minus data obtained during ergo-espirometer divided by data obtained during ergo-espirometer). Data has also been described by means of box plot. Intergroup and intragroup data, regarding respiratory traces and ECG signals, were
Results
As shown in Supplementary Table 1, an overall substantial agreement inter-rater reliability was observed regarding the quality of the respiratory and ECG signals. In the ECG signal, only the QRS complex showed a moderate level of agreement (k = 0.424, p < 0.05).
In Fig. 1, a representative example of all 12-lead ECG and the five respiratory traces (with the sum signal on the bottom right) recorded by L.I.F.E. device is shown. The figure is a screenshot of the monitoring software taken during a
Discussion
This study shows that ECG and respiratory movement monitoring can be performed with high-quality recordings by L.I.F.E. device up to 24 h either in normal subjects and cardiorespiratory patients. For respiratory monitoring, this is not true for high tidal volumes. To the best of our knowledge, L.I.F.E. device is the first cable-less simultaneous 12 ECG leads and respiratory movement recorder, which uses different sensor elements embedded in the fabric of a compressible, easy self-wearable
Conflict of interests
Alessandra Leonardi, Dario Ossola, Rudy Rigoni are L.I.F.E. employees. None participated in data reading.
Andrea Aliverti received a consultation fee from L.I.F.E.
Acknowledgments
Authors contributions: PA and AA had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis, including and especially any adverse effects. AS, CV, SP, CL, AS, FN, MM, PA, and AA contributed substantially to the study design, data analysis and interpretation, and the writing of the manuscript. AL, DO, RR contributed substantially to study design, data interpretation, statistical analysis and writing of the
References (10)
- et al.
Obstructive sleep and atrial fibrillation: pathophysiological mechanisms and therapeutic implications
Int. J. Cardiol.
(2017) - et al.
OSA and cardiac arrhythmogenesis: mechanistic insights
Chest
(2017) - et al.
ECG telemonitoring during home-based cardiac rehabilitation in heart failure patients
J. Telemed. Telecare
(2012) - et al.
2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry
Heart Rhythm.
(2017) - et al.
Rules for scoring respiratory events in sleep: update of the 2007 AASM manual for the scoring of sleep and associated events. Deliberations of the sleep apnea definitions task force of the American Academy of sleep medicine
J. Clin. Sleep Med.
(2012)
Cited by (31)
A multi-stage denoising framework for ambulatory ECG signal based on domain knowledge and motion artifact detection
2021, Future Generation Computer SystemsCitation Excerpt :Electrocardiogram (ECG) records the electrical activity of the heart and is a standard test in many environments (e.g. operating rooms and ambulances) for the detection of heart problems. In recent years, wearable ECG monitoring devices, which are capable of continuous recording for up to one week [1], have been widely used for daily healthcare applications [2,3], and the long-term ECG recordings play an important role in the early diagnosis and prevention of heart diseases [4,5]. Compared with the resting ECG, however, the ECG signals acquired by mobile devices are corrupted by various noises in daily activities, which often lead to unreliable or incorrect diagnosis results.
The wireless revolution and cardiorespiratory system monitoring
2019, International Journal of CardiologyTelemonitoring systems for respiratory patients: technological aspects
2020, PulmonologyCitation Excerpt :An example is L.I.F.E.’s medical compression garment composed of 12 electrodes for ECG monitoring, 5 respiratory strains sensors and 1 accelerometer. The respiratory sensors are based on the variation of the resistance and are positioned on the anterior external surface of the garment as follows: two are thoracic, one is central and two are abdominal.10 Another wearable respiratory monitor is AirGo™, which measures the thoracic circumference changes with a stretchable knitted matrix of nylon and spandex with a built-in silver coated yarn.
Dysregulation of ventilation at day and night time in heart failure
2023, European Journal of Preventive CardiologyWearable Technologies and Stress: Toward an Ethically Grounded Approach
2023, International Journal of Environmental Research and Public Health
- 1
Both authors equally contributed to the present work.