Assessment of the agreement between the snap40 wearable device and accepted measuring techniques in high dependency and the emergency department

ISRCTN ISRCTN17571309
DOI https://doi.org/10.1186/ISRCTN17571309
Secondary identifying numbers 1.5
Submission date
12/07/2016
Registration date
12/07/2016
Last edited
12/07/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
It is widely recognised that the vital signs of a patient change before their condition worsens (deterioration). However, on general medical and surgical wards patient vital signs are often measured at specific times, rather than continuously. Existing continuous monitors are bulky, expensive pieces of equipment that anchor patients to bed. snap40 are developing a discreet wearable device that can be worn on the upper arm to continuously monitor patients, alerting healthcare staff automatically to patient deterioration while allowing complete patient mobility around the hospital. The aim of this study is to assess the difference between vital sign readings collected by snap40's wearable device and the current best method (gold standard) of monitoring vital signs, namely a Draeger intensive care monitor and nursing observations.

Who can participate?
Patients admitted to High Dependency Units (medical or surgical) and the Emergency Department between the ages of 18 and 85 who do not have any implanted electrical medical devices.

What does the study involve?
All participants continue to receive usual care in hospital, but also wear snap40’s wearable device on their upper arm, which consists of an armband with built-in sensors and a rechargeable battery. The device continuously monitors heart rate, respiratory (breathing) rate, blood pressure, oxygen saturations (how much oxygen is present in the blood), skin temperature, movement and perspiration. Patients also have these vital signs measured as usual, through a Draeger IACS intensive care monitor (heart rate, respiratory rate, oxygen saturations, blood pressure) and nursing observations (temperature and neurological status – nerve responses). At the end of the study, vital signs from the snap40 wearable device are compared to gold standard observations to assess the agreement of readings.

What are the possible benefits and risks of participating?
There are no direct benefits involved for those participating in this study. The snap40 armband is small and comfortable to wear so it should not cause discomfort. It doesn’t break the skin and is non-invasive. Personal information about participants will be collected in this study but it will have any information that could identify individual patients removed (anonymised) before it leaves the hospital. The risk of privacy being breached is therefore very low.

Where is the study run from?
Victoria Hospital (UK)

When is the study starting and how long is it expected to run for?
October 2015 to April 2017

Who is funding the study?
snap40 (UK)

Who is the main contact?
Mr Christopher McCann
christopher@snap40.com

Study website

Contact information

Mr Christopher McCann
Public

snap40
125 Princes Street
Edinburgh
EH2 4AD
United Kingdom

Phone +44 1315 601137
Email christopher@snap40.com

Study information

Study designSingle-centre cross-sectional study
Primary study designObservational
Secondary study design
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleSNAPGREE - A cross-sectional observational study in patients in high-dependency and the emergency department to assess the level of agreement between vital signs measured by the snap40 wearable device and gold standard techniques
Study acronymSNAPGREE
Study objectivesThe snap40 wearable device is able to monitor vital signs within an allowable level of agreement to gold standard vital sign monitoring techniques.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedVital sign monitoring
InterventionParticipants are sampled consecutively. Via a Draeger IACs intensive care monitor, participants will have gold standard vital sign measurements taken for blood pressure (via a BP cuff), heart rate (via ECG trace), respiratory rate (via impedance) and oxygen saturations (via pulse oximetry). These are collected on a second-to-second basis. Nursing staff will also collect tympanic temperature and neurological status via AVPU and GCS every hour. Participants will also wear the snap40 armband which collects, on a second-to-second basis heart rate, respiratory rate, blood pressure, oxygen saturation, temperature, movement and perspiration. There will be no follow up with participants.
Intervention typeOther
Primary outcome measureAgreement between vital signs calculated by the snap40 wearable device and accepted measuring techniques is measured by vital signs from the snap40 wearable device and from the Draeger IACs and nursing observations continuously throughout the study.
Secondary outcome measures1. Agreement between the snap40 wearable device and accepted measurement techniques at high and low reading levels is measured by vital signs from the snap40 wearable device and from the Draeger IACs and nursing observations continuously throughout the study
2. Agreement in changes in readings over time between the snap40 wearable device and accepted measurement techniques is measured measured by vital signs from the snap40 wearable device and from the Draeger IACs and nursing observations continuously throughout the study
3. Agreement between the calculation of a National Early Warning Score (NEWS) from readings taken by the snap40 wearable device to a NEWS score calculated from accepted measurement techniques is measured measured by vital signs from the snap40 wearable device and from the Draeger IACs and nursing observations continuously throughout the study
Overall study start date01/10/2015
Completion date30/04/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants170
Key inclusion criteria1. Aged between 18 and 85
2. Male or female
3. Patients from either medical or surgical high dependency or from the emergency department
Key exclusion criteria1. Patients with implantable defibrillators, pacemakers or neurostimulators
2. If there is a difference in blood pressure between arms of greater than 10mmHg (measured at time of recruitment)
Date of first enrolment01/08/2016
Date of final enrolment31/10/2016

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Victoria Hospital
Hayfield Road
Kirkcaldy
KY2 5AH
United Kingdom

Sponsor information

snap40
Industry

125 Princes Street
Edinburgh
EH2 4AD
United Kingdom

Phone +44 1315 601137
Email hello@snap40.com
Website http://snap40.com
ROR logo "ROR" https://ror.org/03a2dk673

Funders

Funder type

Industry

snap40

No information available

Results and Publications

Intention to publish date31/10/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPublication is planned in a high-impact peer reviewed journal within a year of the study completing.
IPD sharing plan