The primary objective is to study whether the (early prototype) sensors are able to reliably measure the vital signs they are designed to record. The secondary objective is to determine the feasibility and user acceptance of the (early prototype)…
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Brief title
Condition
- Other condition
Synonym
Health condition
Dit betreft een validatie studie van continue metingen van vitale functies, welke niet gerelateerd is aan een enkele aandoening of orgaansysteem
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study 1
Primary outcome is the accuracy of the vital sign parameters that each
prototype solution measures as compared with the reference standard.
Study 2
The primary outcome measure of study 2 is the usability of each of the
prototype solutions, as measured with the system usability scale (SUS).
Secondary outcome
The secondary outcome measure of study 2 is the technical feasibility of
ambulatory monitoring at home, which will be evaluated with the following
metrics:
* Success rate of data transmission to external server or gateway device,
calculated as percentage: [(actual data points captured / intended data points)]
o Duration of interrupted monitoring episodes (e.g., data gaps of 15 minutes, 1
hour, 8 hours or more)
o Frequency of interrupted monitoring episodes (e.g., data gaps)
o The level of accessibility of the measured data
Background summary
Hospital in-patients have regular vital signs monitoring to detect clinical
deterioration. On general wards this would be expected to be every 8 hours. Due
to the intermittent nature of this monitoring early signs of deterioration may
be missed and as such, patient deterioration is detected too late or not at
all. This is particularly so as patients are now often more frail, elderly,
with multiple co-morbidities and polypharmacy. Treatments are also getting more
aggressive (e.g. chemotherapy for cancer). Data from across Europe points to
undetected deterioration being one of the biggest patient safety challenges
facing modern healthcare. Therefore, there is a huge unfulfilled need for
better monitoring of vital signs and other data to identify deterioration
earlier and to alert the appropriate personnel. The increase pressure on health
care systems to discharge patients to the community now means vital signs
monitoring is becoming relevant in the home setting.
Within the *Nightingale* project, five leading European academic hospitals
(UMC, Utrecht, the Netherlands; Karolinska, Stockholm, Sweden; University
College London Hospitals, London, United Kingdom; University Hospital Leuven,
Belgium and University Hospital Aachen, Germany) use the European commission*s
Pre-commercial Procurement (PCP) funding scheme to challenge and stimulate
European industry to develop a monitoring system to wirelessly connect patients
and carers to detect deterioration early, be it in the hospital or the home.
As a result, four industrial suppliers have been selected to build early
prototypes for wireless patient monitoring on the general ward and at home
after discharge. If validated, these sensors may provide early detection of
patient deterioration enabling more timely and appropriate intervention within
the near future.
Study objective
The primary objective is to study whether the (early prototype) sensors are
able to reliably measure the vital signs they are designed to record.
The secondary objective is to determine the feasibility and user acceptance of
the (early prototype) sensors when tested at home during daily (freely moving)
activities.
Study design
This protocol describes two substudies that will each address one objective as
described above:
* Study 1 is a methods comparison study in healthy volunteers. It is designed
to assess the accuracy of the sensors. Participants* vital signs will be
recorded from the prototype sensors for 2 hours each. During each 2h session
vital signs from the sensors will be compared with the vital signs recorded
using a CE marked, ICU-grade patient (wired) monitoring system.
* Study 2: comprises a feasibility study in which volunteers will wear the
(early) prototype sensor for a period of five days during their normal daily
activities, both in their home and outside. During a month, volunteers will
wear another sensor every week (from Monday till Friday). The order in which a
participant wears one of the four prototype sensors will be rotated.
Study burden and risks
Both the methods comparison study (Study 1) and feasibility testing at home
(Study 2) will be performed with healthy volunteers which do not need routine
monitoring.
Intended application: the four prototype sensors are:
1.) and 2.): adhesive patch sensors placed on the patient*s chest,
3.) an upper-arm sensor
4.) a soft flexible chest strap.
These positions allow measuring vital signs without the inconvenience of
physical attachment to immobile monitoring systems. All sensors are
lightweight, wireless (no need for cables), and allow untethered measuring of
vital signs while in bed, at home or potentially anywhere. As with any adhesive
plaster/tape, it is possible that some volunteers will experience skin
irritation in response to the adhesives or textiles used, in which case the
sensor will be removed. To prevent any skin irritation, we will ensure that a
participant does not wear two 'patch' sensors in sequence. Since physical
discomfort from the sensors is unlikely, volunteer burden is minimal
Heidelberglaan 100
Utrecht 3508GA
NL
Heidelberglaan 100
Utrecht 3508GA
NL
Listed location countries
Age
Inclusion criteria
Study 1
10 volunteers of both sexes (*18 years of age) are eligible for enrolment, with
the following criteria:
* 5 volunteers need to be at age 65 or above
* 3 volunteers need to have a BMI >30 kg/m2, Study 2
10 volunteers ( *18 years of age) are eligible for enrolment, with the
following criteria:
* At least one hospitalization requiring monitoring in the past two years
(*former patients*)
* Currently healthy or in a stable phase of chronic illness
* 3 volunteers need to have a BMI >30 kg/m2
* 3 volunteers need to live alone (without informal carer)
Exclusion criteria
* Known allergy/skin irritation to the adhesives used in the sensor patches.
* Implanted active medical devices, such as a cardioverter defibrillator or a
pacemaker
* Current pregnancy
* Inability to give informed consent
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL67031.041.18 |