JMIR MHEALTH AND UHEALTH Weenk et al

Original Paper

Continuous Monitoring of Vital Signs Using Wearable Devices on

the General Ward: Pilot Study

Mariska Weenk1, MD; Harry van Goor1, MD, PhD, FRCS; Bas Frietman1, MD; Lucien JLPG Engelen2; Cornelis
JHM van Laarhoven1, MD, PhD, MSc; Jan Smit3, MD, PhD; Sebastian JH Bredie3, MD, PhD; Tom H van de Belt2,
PhD
1
Radboud University Medical Center, Department of Surgery, Nijmegen, Netherlands
2
Radboud University Medical Center, Radboud REshape Innovation Center, Nijmegen, Netherlands
3
Radboud University Medical Center, Department of Internal Medicine, Nijmegen, Netherlands

Corresponding Author:
Mariska Weenk, MD
Radboud University Medical Center
Department of Surgery
P.O. Box 9101
Nijmegen, 6500 HB
Netherlands
Phone: 31 24 361 1111
Fax: 31 24 363 5115
Email: [email protected]

Related Article:
This is a corrected version. See correction statement in: https://mhealth.jmir.org/2021/7/e31899

Abstract
Background: Measurement of vital signs in hospitalized patients is necessary to assess the clinical situation of the patient. Early
warning scores (EWS), such as the modified early warning score (MEWS), are generally calculated 3 times a day, but these may
not capture early deterioration. A delay in diagnosing deterioration is associated with increased mortality. Continuous monitoring
with wearable devices might detect clinical deterioration at an earlier stage, which allows clinicians to take corrective actions.
Objective: In this pilot study, the feasibility of continuous monitoring using the ViSi Mobile (VM; Sotera Wireless) and
HealthPatch (HP; Vital Connect) was tested, and the experiences of patients and nurses were collected.
Methods: In this feasibility study, 20 patients at the internal medicine and surgical ward were monitored with VM and HP
simultaneously for 2 to 3 days. Technical problems were analyzed. Vital sign measurements by nurses were taken as reference
and compared with vital signs measured by both devices. Patient and nurse experiences were obtained by semistructured interviews.
Results: In total, 86 out of 120 MEWS measurements were used for the analysis. Vital sign measurements by VM and HP were
generally consistent with nurse measurements. In 15% (N=13) and 27% (N=23) of the VM and HP cases respectively, clinically
relevant differences in MEWS were found based on inconsistent respiratory rate registrations. Connection failure was recognized
as a predominant VM artifact (70%). Over 50% of all HP artifacts had an unknown cause, were self-limiting, and never took
longer than 1 hour. The majority of patients, relatives, and nurses were positive about VM and HP.
Conclusions: Both VM and HP are promising for continuously monitoring vital signs in hospitalized patients, if the frequency
and duration of artifacts are reduced. The devices were well received and comfortable for most patients.

(JMIR Mhealth Uhealth 2017;5(7):e91) doi: 10.2196/mhealth.7208

KEYWORDS
remote sensing technology; vital signs; wireless technology; continuous monitoring

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Introduction Methods
In hospitalized patients, vital signs are measured to assess the Setting and Recruitment
clinical situation of the patient and to identify clinical Patients hospitalized in the internal medicine and surgical ward
deterioration [1]. Monitoring of these vital signs is usually done of the Radboud University Medical Center were included
by nurses, and includes blood pressure (BP), heart rate (HR), between December 2014 and March 2015. All consecutively
respiratory rate (RR), blood oxygen saturation, and core admitted patients were approached for participation if they were
temperature. Early warning scores (EWS) are physiological hospitalized for at least 48 hours, and MEWS measurements
track-and-trigger systems, which use a multiparameter or were ordered at least three times a day by their medical doctor.
aggregate weighted scoring system that assists in detecting Patients had to be 18 years or older and able to speak, read, and
physiological changes and thereby identify patients at risk for understand the local language. At the internal medicine ward,
further deterioration [2,3]. The modified early warning score both VM and HP were attached to the patient after signed
(MEWS) is a commonly used and validated EWS system (see informed consent was obtained. At the surgical ward, patients
Multimedia Appendix 1) [4-6]. A higher MEWS is associated signed informed consent before an elective surgical procedure.
with admissions to the intensive care unit (ICU), cardiac arrest, Both devices were attached to the patients after surgery and
and mortality [7-9]. Since the introduction of EWS, a trend was arrival at the ward. Patients were excluded from further analyses
seen toward a decrease in unplanned admissions to the ICU and if they unexpectedly participated for a duration shorter than 24
a decrease in hospital mortality [10-16]. Although the EWS hours in the study. To determine the technical feasibility and
provides relevant data on patients’ health status, the interval practical usability, the two wearable devices were used to
measurements may not capture early deterioration of vital signs continuously measure vital signs in patients, which were
[17], particularly during the night when clinical deterioration compared with regular data collected in the same patients. Since
may remain undetected until the next day [18]. This could a formal power calculation was not feasible due to the lack of
explain why the majority of the unplanned ICU admissions take preliminary data with these monitoring systems, a sample size
place between 8 am and 4 pm [19]. Unplanned ICU admissions of 20 was estimated to obtain sufficient data for analysis. After
are associated with an increased mortality rate, a longer hospital reviewing the study protocol, the institutional review board
stay [20-22], and a 60% increase in hospitalization costs [23]. waived the need for formal review and approval (number
Continuous monitoring of vital signs could be a useful tool to 2014-1434).
detect clinical deterioration in an earlier phase, which allows
clinicians to take corrective interventions, particularly since ViSi Mobile
subtle changes in vital signs often are present 8 to 24 hours The VM system has received Conformité Européenne (CE)
before a life-threatening event such as ICU admission, cardiac mark and is FDA-cleared for continuously monitoring of 3- or
arrest, and death [13,24-27]. Nowadays, wearable devices that 5-lead electrocardiogram (ECG), heart and pulse rate, blood
facilitate remote continuous monitoring of vital signs exist [28]. oxygen saturation, RR, skin temperature, and BP (cuff-based
These wireless devices could reduce patient discomfort due to and cuff-less on beat-to-beat basis; Figure 1). All vital signs are
fewer measurements by nurses [29-31], allow patient mobility displayed on a patient-worn wrist device, which can be locked
[31], and might reduce workload for nurses [30]. Moreover, by an authentication code. This wrist device is connected to a
wearable devices are promising for safe patient transports thumb sensor, which measures blood oxygen saturation and BP.
between wards, the operating room, and the radiology A chest sensor measures RR and skin temperature, and is
department [32]. However, these devices are still underutilized connected with 3 or 5 ECG cables and sensors. In this pilot
in health care, even though they have been shown to be accurate study, VM was wirelessly connected to a stand-alone Toughbook
[17,33], and may reduce costs [34]. Despite many potential (Panasonic) pre-installed with VM software, from where the
advantages, wearable devices may have disadvantages regarding investigators received real-time insights on patients’ vital signs
technical dysfunction and adverse psychological effects and where all the data were stored. This Toughbook also showed
increasing anxiety of patients for disturbances of vital signs alarms as soon as vital signs dropped out of normal ranges. The
[33]. VM wrist device was powered by rechargeable batteries, which
Recently, ViSi Mobile (VM; Sotera Wireless) and HealthPatch needed to be replaced every 12 to 14 hours.
(HP; Vital Connect), two new devices approved by the US Food HealthPatch
and Drug Administration (FDA) for wireless remote monitoring
The HP consists of a reusable sensor and a disposable adhesive
of vital signs, were introduced in health care. At present, little
patch with 2 ECG electrodes at the bottom of the patch and a
is known about the feasibility of continuous monitoring and
reusable sensor (see Figure 1). The HP has received CE mark
experiences of patients and caregivers. The objective of this
and is FDA-cleared for continuous measurement of single-lead
pilot study was to assess the technical feasibility of continuous
ECG, HR, heart rate variability (HRV), RR, skin temperature,
monitoring with these new devices and to evaluate the
body posture, fall detection, and activity. This small and
experiences of patients and nurses with this method of
lightweight patch can be attached to the patient’s chest, from
monitoring on the general ward.
where the data is transmitted to a mobile device (eg, mobile
phone, via Bluetooth). Wi-Fi connection facilitates data
transmission from the mobile device to a secured cloud server.
The patch is powered by a coin-cell battery that lasts 3 to 4 days.
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Figure 1. ViSi Mobile system (left) and HealthPatch (right).

Data Collection and Analysis

Study Procedures
Patients gave verbal and written consent after being informed Technical Feasibility
about the study protocol. Demographics including gender, age, All registered data from VM and HP were retrieved for analysis
reason for admission, and type of surgery were collected. At in the Statistical Package for the Social Sciences version 20.0
the surgical ward, VM and HP were attached to the patient after (SPSS, Inc). Data of both devices were compared with
surgery and arrival at the ward. At the internal medicine ward, measurements by nurses at the same time points. For each
both devices were attached to the patient directly after signed variable, the accepted discrepancy between nurse measurements
informed consent was obtained. Vital signs were continuously and both devices was determined, which are listed in Table 1.
measured during 2 or 3 days. This time frame was chosen to These thresholds were defined as the maximum possible
obtain enough vital sign data for analysis and to allow patients discrepancy in vital signs between the nurse measurements and
to get familiar with the devices. Nurses measured vital signs both devices that would not lead to a change in medical
three times daily according to the protocol. Trained medical treatment. A difference in MEWS score of 1 point or more
students additionally observed time-related vital signs monitored between the nurse measurements and both devices was defined
by VM at the Toughbook and HP on the cloud server. They as a clinically relevant difference. The MEWS scores were
marked the time points where vital signs were taken by the nurse calculated using vital signs measured by the nurses, VM, and
and manually selected the results for vital signs measured by HP. As VM and HP did not measure all required vital signs to
both devices at these time points for comparison. They also calculate the MEWS score, such as level of consciousness, these
registered the cause and duration of technical problems and vital signs were taken from the electronic health records (EHR).
fixed them when necessary. In case of a VM alarm, the student Bland-Altman plots [35] were created to assess the agreement
warned the nurse. After 2 to 3 days, the enrolled patients and between MEWS measurements by nurses and corresponding
their relatives were interviewed about their experiences values of VM and HP. All artifacts ≥1 minute were analyzed,
regarding continuous monitoring and both wearable devices. since we reasoned that artifacts of less than one minute would
Nurses involved in the care of included patients were not be clinically relevant for a patient’s situation. An artifact
interviewed as well. had occurred if no or an invalid value was recorded. Since
trained medical students were not present all the time (primarily
not during out-of-office hours), artifacts were divided into two
groups, depending on the presence of a student.

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Table 1. Accepted discrepancies between nurse measurements, ViSi Mobile, and HealthPatch.
Vital sign Accepted discrepancy
Heart rate 5 beats/min
Respiratory rate 2 breaths/min
Oxygen saturation 2%

Temperaturea 0.5˚C

Blood pressure 5 mm Hg
MEWS 1

a
ViSi Mobile and HealthPatch measure skin temperature.

participation because they thought it would be too much of a

Practical Usability mental or physical burden (see Figure 2). The study population
User experiences were obtained by means of semistructured included 13 males and 7 females with a mean age (standard
face-to-face interviews, after the patients had used the devices deviation, SD) of 49.9 (13.4) years, ranging between 33 and 82
for 2 to 3 days. Patients’ relatives and nurses were also years. At the surgical ward, most patients were admitted for an
interviewed. Interviews lasted approximately 10 minutes and elective gastrointestinal operation. Patients at the internal
the following topics were discussed: feelings of unsafety or medicine ward were admitted for several conditions such as
safety, user friendliness, adverse events, and detection of clinical sepsis, arthritis, and blood pressure control.
deterioration. One researcher (MW) performed a thematic
content analysis to determine perceived positive and negative Technical Feasibility
effects, and facilitators and barriers, which was critically In total, 120 vital sign measurements by nurses were observed
reviewed by a second researcher (TB). Perceived positive and by the trained medical students (see Figure 2). In 40
negative effects were presented according to the Donabedian measurements, one or more vital signs were missing. In 6
framework for the quality of health care [36], which includes measurements, data were completed by consulting the EHR.
three main domains: structure, process, and outcome. Facilitators As a result, 86 measurements were used for further analysis.
and barriers were divided into four domains: characteristics For the remaining 34 measurements, VM and HP data were
related to the patient, professional, intervention, and context lacking (25 measurements), or vital signs were not documented
[37]. by nurses (9 measurements). In 8 patients, data from the
Toughbook was not available for further analysis due to
Results accidental deletion of data; in 2 patients, no HP data were saved
at the cloud server due to technical failures (eg, WiFi failures,
Demographics disconnection between HP and its mobile device). In total, 742.8
A total of 25 patients were invited, of which 20 participated in hours of VM data and 1033.6 hours of HP data were collected;
the study—10 patients at the surgical ward and 10 patients at on an average 61.9 hours of VM and 57.5 hours of HP data were
the internal medicine ward. The other 5 patients refused collected per patient.

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Figure 2. Included patients and vital sign measurements.

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Figure 3. Bland-Altman plots: (a) heart rate (VM and HP), (b) respiratory rate (VM and HP), (c) systolic and diastolic blood pressure (VM). Dotted
lines indicate mean difference and solid lines indicate limits of agreement.

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Figure 4. Bland-Altman plots showing modified early warning score: (a) VM and HP, (b) VM and HP (jittered). Dotted lines indicate mean difference
and solid lines indicate limits of agreement.

nurses (range: 1-6 breaths/min), and in the four other cases,

Vital Signs nurses measured a higher RR than VM (difference: 2-6
Bland-Altman plots showing the mean of the two devices and breaths/min). In the three remaining cases that resulted in a
the differences between the two devices (y-axis) with limits of different MEWS, there was a difference in systolic BP
agreement (1.96 SD) are displayed in Figures 3 and 4. (difference: 14 mm Hg) or oxygen saturation (difference:
Comparing the results for vital signs and MEWS score measured 1%-5%) between VM and the nurse. The mean differences
by nurses and VM, the mean differences were all within range between nurse measurement and HP were all in agreement with
with the predefined accepted discrepancies in Table 1, although accepted discrepancies, although wide limits of agreement were
wide limits of agreement were found (see Table 2). The largest found (see Table 2). In 23 (27%) cases, MEWS differed 2 or 3
discrepancy in the mean difference was found for diastolic BP. points between HP and nurse measurements (see Table 3). In
In 13 (15%) cases, the MEWS difference between nurse and 17 cases, HP measured higher RR compared with nurses. In 16
VM was 2 points or higher, indicating important clinical cases, differences were in the range of 3 to 8 breaths/minute.
differences between VM and nurse measurements (see Table However, in one case, nurses measured 16 breaths/minute and
3). In four cases, this was related to differences in RR alone. In HP measured 42 breaths/minute, indicating possible
the remaining cases, the combination of RR and oxygen measurement errors in HP. In the remaining six cases, nurses
saturation, or RR and systolic BP caused the difference. measured a higher RR than HP (difference: 4-12 breaths/min).
Moreover, in six of these cases, VM measured a higher RR than

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Table 2. ViSi Mobile and HealthPatch data in comparison with corresponding nurse measurements.
Vital signs Nurse ViSi Mobile HealthPatch

Mean (SD)j Mean (SD) Mean difference (SD) Mean (SD) Mean difference (SD)
versus nurse versus nurse

HRf (beats/min) 81.81 (13.12) 81.62 (12.23) −0.20 (5.54) 84.34 (12.24) −1.52c (5.63)

RRg (breaths/min) 17.38 (3.89) 16.20 (4.57) 1.19a (3.43) 18.02 (5.82) −0.64 (4.94)

Saturation (%) 97.00 (96.00 to 98.00)d 97.00 (95.00 to 98.00)d 0.10 (1.65) N/Ak N/A

Temperature (˚C) 37.01 ( 0.60) 33.61(1.25)e 34.16 (1.16)e

N/A
BPh, systolic (mm Hg) 127.93 (19.33) 127.49 (18.68) 0.44 (11.99) N/A

BP, diastolic (mm Hg) 73.17 (10.25) 81.17 (11.24) N/A N/A
−8.00b (9.93)

MEWSi 0.99 (1.13) 1.38 (1.30) −0.40a (1.13) 1.59 (1.54) −0.60b (1.22)

a
P=.002.
b
P<.001.
c
P=.01.
d
Oxygen saturation was reported as median with interquartile range.
e
Skin temperature.
f
HR: heart rate.
g
RR: respiratory rate.
h
BP: blood pressure.
i
MEWS: modified early warning score.
j
SD: standard deviation.
k
N/A: Not applicable.

HealthPatch
Artifacts
In total, 648 artifacts were found in 18 patients, with a total time
ViSi Mobile of 135 hours. More than 50% (n=354) of all artifacts lasted less
In total, 306 artifacts were found, with a total time of 121 hours. than 1 minute and were excluded from further analysis. In the
In 111 (36.3%) of 306 artifacts, a trained medical student was remaining 294 artifacts, a trained medical student was present
present, and 86 of 111 (77.5%) were identified and reported. A in 60% (n=176) of the artifacts, and identified and reported the
cause was found in 82 (95.1%) of 86 artifacts. Almost 70% of artifact in 53 (30%) cases. A cause was found in 24 (45%)
all reported artifacts were caused by connection failure between artifacts such as HealthPatch losing skin contact (n=13, 54%),
Toughbook and VM. Other artifact causes were motion of the Bluetooth (n=4, 17%) or Wi-Fi problems (n=3, 13%), and
sensors due to patient movements (n=21, 25.6%) and required patients leaving the ward without their mobile device (n=3,
calibration of blood pressure (n=2, 2.3%). Over 74% of all 13%). Around 43% of all artifacts lasted less than 5 minutes.
artifacts lasted less than 5 minutes. Almost 20% lasted less than Over 95% of all artifacts lasted less than 1 hour.
1 hour, and approximately 7% lasted longer than 1 hour.

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Table 3. ViSi Mobile (VM) and HealthPatch (HP) data in comparison with corresponding nurse measurements.
Vital signs ViSi Mobile HealthPatch
Difference; nurse-VM (%) Difference; nurse-HP (%)

HRa (beats/min) ≤5: 71 (82.5) ≤5: 65 (75.6)

6-10: 12 (14.0) 6-10: 16 (18.6)

>10: 3 (3.5) >10: 5 (5.8)

RRb (breaths/min) ≤2: 50 (58.2) ≤2: 36 (41.9)

3-5: 26 (30.2) 3-5: 31 (36.0)

>5: 10 (11.6) >5: 19 (22.1)
Saturation (%) ≤2: 76 (88.4) N/Ae
3-4: 9 (10.5)
≥5: 1 (1.1)

BPc systolic (mm Hg) ≤5: 36 (41.9) N/A

6-14: 33 (38.4)
≥15: 17 (19.7)
BP diastolic (mm Hg) ≤5: 27 (31.4) N/A
6-14: 40 (46.5)
15: 19 (22.1)

MEWSd −4: 1 (1.2) −3: 9 (10.5)

−3: 5 (5.8) −2: 11 (12.8)

−2: 4 (4.7) −1: 13 (15.1)
−1: 23 (26.7) 0: 47 (54.7)
0: 40 (46.5) 1: 3 (3.5)
1: 10 (11.6) 2: 2 (2.3)
2: 3 (3.5) 3: 1 (1.2)

a
HR: heart rate.
b
RR: respiratory rate.
c
BP: blood pressure.
d
MEWS: modified early warning score.
e
N/A: not applicable.

Being monitored continuously is a very pleasant

Practical Usability experience; I felt very safe. [Translated from Dutch]
Evaluations were performed with all 20 patients, 7 relatives, Earlier interventions were deemed possible in case of clinical
and 4 nurses (see Table 4). deterioration (n=3). One negative effect was identified; one
Perceived Positive and Negative Effects patient complained about having redness and itching while
wearing the devices.
Processes
One positive effect was identified in this dimension. Patients Facilitators and Barriers
stated that nurses could keep an eye on the vital signs from a Intervention
distance (n=3); this was also mentioned by one relative. No Seven facilitators were identified. Eight patients said they were
negative effects were identified. not aware of the HP while it was attached to their chest. Other
Outcomes facilitators included not being restricted by the devices during
Two positive effects were identified in this dimension. Eight daily activities such as bathing and putting on clothes (n=3),
patients and 66 relatives mentioned increased feelings of safety more freedom of movements compared with conventional
by being monitored continuously in comparison with the MEWS devices (n=2), the small size of the HP (n=1), the good adhesive
measurements by nurses only. A patient described: properties of the patches (n=1), and the invisibility of the devices
under clothes (n=1). One patient described:

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I have used a holter monitor at home several times. while washing the patient, and one nurse said that it was very
These devices are much smaller and they do not limit easy to attach the devices to the patient. One nurse mentioned
mobility to the same extent. [Translated from Dutch] that Wi-Fi connection was poor between Toughbook and the
One patient experienced great advantage of having an insight VM device.
on his own vital signs. One barrier was noted 15 times. Patients Additional Findings
mentioned that the VM wrist device was big or heavy (n=10);
patches came off very quick (6 VM; 2 HP); VM had many During the study, clinical deterioration was detected with the
cables (n=4); and VM had a short battery life (n=2). VM in one patient 3 days postoperatively after elective
colorectal surgery. The device alerted the nurse who cared for
Professional the patient because he developed a tachycardia and tachypnea.
Two facilitators and one barrier were identified in this domain. This situation occurred between two regular measurements. He
Two nurses stated that the patches did not lose skin contact underwent relaparotomy after an anastomotic leak was
confirmed by computer tomography.

Table 4. Users’ experiences.

Users’experience Nurse Patient Relatives
Perceived positive and negative effects

Processesa
Nurse could keep eye on vital signs more easily + +
Outcomes
Feelings of safety + +
Earlier interventions +
Adverse events (redness and itching) −
Barriers and facilitators
Intervention

Not aware of HPb +

Small size of HP +
Good adhesive properties +
Not being restricted during daily activities +
More freedom of movements +
Invisibility under clothes +
Better insight on own vital signs +

VMc wrist device too big/heavy −

Patches came off very quickly −

VM has too many cables −
Short VM battery life −
Professional
Good adhesive properties +
Very easy to attach the devices +
Bad Wi-Fi connection between VM and Toughbook −

a
No positive or negative effects in the “Structure” or “Context” fields were found.
b
HP: HealthPatch.
c
VM: ViSi Mobile.

recently released wireless devices. In general, data obtained by

Discussion these devices correlated well with predefined accepted
Principal Findings discrepancies and MEWS calculated on the basis of these
devices correlated to a larger extent. Patients and nurses were
This study describes a unique approach in which we mainly positive about the two devices. Both VM and HP are
continuously measured vital signs on the ward using two
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promising devices for continuous patient monitoring on the Although HP could not measure all vital signs that are currently
general ward. However, the number of artifacts should be used to monitor patients and to calculate the MEWS, it may
reduced and the barriers mentioned by the users could be still provide more patient data than interval measurements by
addressed to further improve both devices. nurses, resulting in a more continuous dataflow and more
specific trends. This may be of significance, in particular, since
Vital Signs literature shows important lack of documentation of vital signs
The largest discrepancy in mean difference was found in VM before a life-threatening event [27]. Besides that, several studies
diastolic blood pressure, which is unlikely to be directly show that HR and RR change significantly before ICU transfer,
clinically meaningful since it is not a component of the MEWS. cardiac arrest, and mortality and therefore, HP can have a
Additionally, clinical decisions are mainly based on systolic valuable contribution to the prediction of life-threatening events
blood pressure and other vital signs. Wide limits of agreement [24,27].
were found for almost all vital signs and MEWS. Although
more than 70% of all MEWS differed 0 or only 1 point between Practical Usability
devices and nurse measurements, larger differences in MEWS The majority of patients, relatives, and nurses were positive
were found in a few cases, which may have important clinical about VM and HP. Whereas HP is able to administer vital signs
consequences (eg, additional diagnostic procedures or change in real time to patient’s mobile phone, VM shows vital signs in
in treatment). In most of these cases, VM and HP measured a real time on the wrist device; these devices could therefore
higher RR when nurses did not. Although most differences increase insight on patient’s health status and potentially
between nurse and device measurements were small (<5 influence their behaviors [45,46]. Although patients mentioned
breaths/min), in one case, difference between nurse and HP that the VM wrist device was heavy and VM consisted of many
measurements was large (26 breaths/min). These findings are cables, they were not restricted during daily activities or
important as abnormal RR has been shown to be an important mobility. This is important as hospitalized patients benefit from
predictor of cardiac arrest [38] and an indicator of sepsis, mobility, resulting in increased recovery and reduced risk of
pneumonia and respiratory depression [39]; therefore, it could complications [47,48]. Another benefit of VM and HP is that
under- or overestimate a clinical condition of a patient. nurses are able to see patients’ vital signs from a distance. A
Inaccurate RR measurements by nurses could explain the review by Ulrich et al [49] has shown that sleep deprivation in
discrepancy. Direct measurement of RR is usually done by patients is a common problem that is associated with hindrance
visually observing chest movement or by manual observations. of the healing process and an increase in morbidity and
Reproducibility may be limited by significant interobserver mortality. Using VM and HP, patients could continue sleeping
variability [40]. Conversely, ECG-derived RR measurements during the night and did not have to be disturbed by vital sign
by HP and VM may be inaccurate. In case of HP, RR is measurements.
estimated by ECG using the respiratory sinus arrhythmia
Possible negative aspects of continuous monitoring should also
method, which derives RR from HRV. Since this method has
be taken into consideration. Wearable devices generate a large
some limitations, an accelerometer was added to measure RR
quantity of data each day. The workload of nurses and
more accurately [41]. In VM, RR is derived from impedance
physicians withholds them from inspecting all these data, which
pneumography, measuring respiratory volume and rate through
means that the predictive value of continuous monitoring is lost
the relationship between respiratory depth and thoracic
[17]. Validated devices are available to process all these data
impedance rate [42]. ECG-derived RR may not be accurate
and to send an alert when patient’s vital signs drop out of normal
when there is excessive patient motion or during lower
ranges. A large number of alerts and even false-positive alerts
respiratory rates [43,44]. More research is required to gain a
could cause alarm-fatigue in nurses [17,50]. Algorithms using
deeper insight in the different methods of measuring RR by
machine learning could be utilized to reduce false-positive
devices and nurses.
alarms [51-53]. The VM battery has a battery life of 12 to 14
Artifacts hours, which means that nurses have to change batteries twice
Most reported that VM artifacts concerned connectivity failure a day. This might outweigh the fact that nurses no longer need
between VM and Toughbook. This was caused by a restricted to perform the standard MEWS measurements three times a
Wi-Fi connection of approximately 15 meters between VM and day.
Toughbook, which explains why more artifacts were found in Comparison With Prior Work
mobile patients. These artifacts were not deemed relevant since
A few studies about continuous monitoring at the general ward
more stable Wi-Fi connections, such as by using multiple access
have been published. A wireless sensor was successfully used
points and 5 Ghz networks, would be used to implement VM
in pregnant women in an inpatient obstetric unit, which was
in a hospital setting. This would also facilitate continuous
able to monitor HR, RR, and temperature [30]. Recently, the
monitoring during patient transport between different wards.
SensiumVitals digital patch was tested in hospitalized patients
However, it is important to consider that a wireless connection
[54]. This patch is able to measure HR and RR and was
can always fail, thus proper backup power and Internet
compared with a commonly used clinical monitor. A satisfactory
connections are always demanded. Most HP artifacts were of
agreement, comparable with the result in our study, was shown.
unknown cause. However, most artifacts lasted less than one
The drawback of the study design was that the patients were
hour and were self-limiting.
monitored for only 2 hours, which prevented the authors from
detecting trends in vital signs and lowered predictive value. The

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use of an implantable device for continuous monitoring has due to wrong Toughbook settings and was changed with support
been described in the ambulatory setting. Abraham et al [55] from the manufacturer. The VM vital signs observed by students
described the use of a wireless implantable hemodynamic were used for the comparison with nurse measurements, and
monitoring system in heart failure patients, which has shown we were therefore able to draw conclusions about the feasibility
to reduce hospitalization. Wireless technology systems in which of both VM and HP. However, data saturation in patient, nurse,
patients measure vital signs at home have been described, such and relative interviews may not have been reached. Selection
as for patients with chronic obstructive pulmonary disease [56], bias could have occurred as not all patients who were
patients with hypertension [57], and patients with diabetes approached did agree to participate. A further limitation of VM
mellitus [58,59]. These systems were often well received by and HP is that both devices measure skin temperature instead
patients and health care providers, showing improvement of of body temperature. Although it is not yet clear whether or not
blood values such as glucose [58,60], patients’ disease all vital signs are necessary for proper clinical judgment of ill
management [56,61], and better connection between the patient patients, an algorithm should be developed to convert skin
and the health care provider [59]. Particularly, the HP might be temperature into body temperature.
suitable for home monitoring, although its current version lacks
the possibility to measure all vital signs. Though VM measures
Conclusions
all vital signs, its size and cables might demand much from The VM and HP are promising devices for wireless continuous
patients to enable monitoring at home. patient monitoring in the hospital and were very well received
by both patients and nurses. The frequency and duration of
Strength and Limitations artifacts should be reduced and the barriers mentioned could be
An important strength of the study is that we were able to addressed to further improve VM and HP. An ongoing follow-up
monitor patients in a clinical setting instead of healthy study focuses on the different effects of VM or HP compared
participants in controlled settings. The study had a small sample with routine MEWS measurements on patient comfort and safety
size, and we missed some VM and HP data, particularly since and nurse workload, and on early detection of deterioration.
VM data of 8 patients were automatically deleted from the Future studies should focus on the effect of continuous
Toughbook and could not be used for artifact analysis. This was monitoring on clinical outcome.

Acknowledgments
The project was funded by the Radboud University Medical Center.

Conflicts of Interest
None declared.

Multimedia Appendix 1
Modified Early Warning Score (MEWS); A: alert, V: response to speaking, P: response to pain, U: no response.
[JPG File, 48KB-Multimedia Appendix 1]

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Abbreviations
BP: blood pressure
CE: Conformité Européenne
ECG: electrocardiogram
EHR: electronic health records
EWS: early warning scores
FDA: US Food and Drug Administration
HP: HealthPatch
HR: heart rate
ICU: intensive care unit
MEWS: modified early warning score
RR: respiratory rate
SD: standard deviation
VM: ViSi Mobile

Edited by G Eysenbach; submitted 21.12.16; peer-reviewed by D Maslove, J Boyd, JH Lee; comments to author 26.02.17; revised
version received 12.04.17; accepted 25.05.17; published 05.07.17
Please cite as:
Weenk M, van Goor H, Frietman B, Engelen LJLPG, van Laarhoven CJHM, Smit J, Bredie SJH, van de Belt TH
Continuous Monitoring of Vital Signs Using Wearable Devices on the General Ward: Pilot Study
JMIR Mhealth Uhealth 2017;5(7):e91
URL: http://mhealth.jmir.org/2017/7/e91/
doi: 10.2196/mhealth.7208
PMID: 28679490

©Mariska Weenk, Harry van Goor, Bas Frietman, Lucien JLPG Engelen, Cornelis JHM van Laarhoven, Jan Smit, Sebastian JH
Bredie, Tom H van de Belt. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 05.07.2017. This is
an open-access article distributed under the terms of the Creative Commons Attribution License
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