Condition category
Not Applicable
Date applied
12/07/2016
Date assigned
12/07/2016
Last edited
12/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

http://snap40.com

Contact information

Type

Public

Primary contact

Mr Christopher McCann

ORCID ID

Contact details

snap40
125 Princes Street
Edinburgh
EH2 4AD
United Kingdom
+44 1315 601137
christopher@snap40.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.5

Study information

Scientific title

SNAPGREE - 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

Acronym

SNAPGREE

Study hypothesis

The snap40 wearable device is able to monitor vital signs within an allowable level of agreement to gold standard vital sign monitoring techniques.

Ethics approval

Not provided at time of registration

Study design

Single-centre cross-sectional study

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Vital sign monitoring

Intervention

Participants 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 type

Other

Phase

Drug names

Primary outcome measures

Agreement 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 measures

1. 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 trial start date

01/10/2015

Overall trial end date

30/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 85
2. Male or female
3. Patients from either medical or surgical high dependency or from the emergency department

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

170

Participant exclusion criteria

1. 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)

Recruitment start date

01/08/2016

Recruitment end date

31/10/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Victoria Hospital
Hayfield Road
Kirkcaldy
KY2 5AH
United Kingdom

Sponsor information

Organisation

snap40

Sponsor details

125 Princes Street
Edinburgh
EH2 4AD
United Kingdom
+44 1315 601137
hello@snap40.com

Sponsor type

Industry

Website

http://snap40.com

Funders

Funder type

Industry

Funder name

snap40

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication is planned in a high-impact peer reviewed journal within a year of the study completing.

Intention to publish date

31/10/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes