Vital SignsSNAP40EDNCT03179267
Detection of Deterioration by SNAP40 Versus Standard Monitoring in the ED
A study testing SNAP40 in people with Vital Signs, run by NHS Lothian at 1 site in United Kingdom.
Trial summary
In recent years there has been increasing focus on the earlier detection of deterioration in the clinical condition of hospital patients with the aim of instigating earlier treatment to reverse this deterioration and prevent adverse outcomes. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Vital Signs
- What is being tested?
- SNAP40
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Sep 2017to 22 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant aged 16 years or over AND
- Participant triaged to Majors (High Dependency or Immediate Care) OR Participants who are stepped down from Resuscitation room care to High Dependency or Immediate Care
Who cannot join
- Participants under 16 years of age
- Previous participation in the study
- Participant in custody
- Participants deemed high risk for absconding by clinical staff
- Participants unable to communicate in English
- Participants who are triaged to immediate resuscitation. These participants may be considered for inclusion once immediate assessment and treatment have been initiated and they are stepped down to High Dependency (HD)/Immediate Care (IC) areas
- Patients with implantable defibrillators, pacemakers or neurostimulators will be excluded
- Patients who cannot have blood pressure measured in both arms e.g. patients with renal fistula, a Peripherally Inserted Central Catheter (PICC) line or who have had a lymph node clearance
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, EH16 4SA
About this study
Official title: Detection of Physiological Deterioration by the SNAP40 Wearable Device Compared to Standard Monitoring Devices in the Emergency Department
In recent years there has been increasing focus on the earlier detection of deterioration in the clinical condition of hospital patients with the aim of instigating earlier treatment to reverse this deterioration and prevent adverse outcomes. This is especially important in the ED, a dynamic environment with large volumes of undifferentiated patients, which carries inherent patient risk. SNAP40 is an innovative medical-grade device that can be worn on the upper arm that continuously monitors patients' vital signs including relative changes in systolic blood pressure, respiratory rate, heart rate, movement, blood oxygen saturation and temperature. It uses automated risk analysis to potentially allow clinical staff to easily and quickly identify high-risk patients. The aim of this study is to investigate whether the SNAP40 device is able to identify deterioration in the vital sign physiology of an ED patient earlier than current standard monitoring and observation charting techniques.
Read the detailed description
As well as the potential of the SNAP40 device to improve patient safety, we believe that the SNAP40 device will increase ED efficiency, improve and increase use of resources and enable improved patient flow through the ED. Currently the only option for continuous monitoring or regular observations in the ED is to connect the patient to a standard monitor. Whilst these monitors can be portable they are not lightweight enough to allow the patient to be ambulatory within the ED and therefore require the patient to have a bed and a bed space or cubicle. This leads to lack of space within the ED, less cubicles (which allow privacy) free for performing history taking, examination and procedures, difficulty accessing patients and difficulty transporting them to areas where specialist tests can be performed (i.e. radiology and ECG). SNAP40 may remove the need for patients to be confined to beds and bed spaces (unless clinically required) freeing up space within the ED and allowing the ED care processes to occur much more freely increasing efficiency and speed of patient processing. This will undoubtedly lead to improved patient experiences around their ED and hospital journey.
The SNAP40 device also has the potential to free up resources, which can be used to improve patient care and experience in the ED. SNAP40 may reduce clinical staff time taken to record observations enabling them to provide patients with other aspects of care (i.e. analgesia and treatments) more regularly and in a timelier manner. Clinical staff may be able to spend more time with patients allowing better quality communication with them and their relatives. There will potentially be more time for traditional nursing care and personal care.
Whilst there are some other similar medical devices on the market (i.e. www.biovotion.com, www.sensium-healthcare.com, www.vitalconnect.com, http://www.caretakermedical.net) using wristbands, patches or finger cuff technology, currently none are being used in ED clinical practice.
This study will examine the SNAP40 device by comparing its performance to detect physiological deterioration against standard observations taken by clinical staff (nurses, doctors and clinical support workers) within the ED. The study will assess whether the device is able to detect physiological derangement sooner that standard monitoring devices.
- Conditions
- Vital Signs
- Being tested
- SNAP40
- Keywords
- vital signs, monitoring, early warning score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNAP40Device
SNAP40 ambulatory monitoring device
| Study group | Role | What they receive |
|---|---|---|
| SNAP40 monitor | Experimental | All participants in the study will be fitted with the SNAP40 ambulatory monitoring device as well as usual monitoring as standard care Receives: Device: SNAP40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to detection of deterioration
Time to detection of deterioration in an ED patient's vital sign physiology defined as an increase in NEWS score. This would include a deterioration in blood pressure, pulse/heart rate, respiratory rate, skin temperature (SNAP40)/core temperature (Standard), oxygen saturation reading or movement (SNAP40)/GCS (Standard).
Measured: 4 hours
Secondary outcomes (4)
Staff observation and responding to alarm times
Time ED staff spend performing a charting observations and responding to standard monitoring alarms.
Measured: 4 hours
Percentage clinical escalation of care when deterioration detected.
Percentage clinical escalation of care when deterioration detected.
Measured: 4 hours
Participants satisfaction
Participants rating of experience of both SNAP40 and current monitoring.
Measured: 4 hours
Staff satisfaction
ED staff rating of experience of both SNAP40 and current monitoring.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start25 Sep 2017
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vital SignsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Addition to standard care
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Collaborators
- SNAP40, University of Edinburgh
- Responsible party
- Sponsor
- Investigators
- Matt Reed, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179267
- Sponsor's protocol ID
- 17/SS/0028
- Acronym
- SNAP40ED
- Status last verified
- Apr 2017
- First submitted
- 6 Jun 2017
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reed MJ, McGrath M, Black PL, Lewis S, McCann C, Whiting S, O'Brien R, Grant A, Harrison B, Skyrme L, Odam M. Detection of physiological deterioration by the SNAP40 wearable device compared to standard monitoring devices in the emergency department: the SNAP40-ED study. Diagn Progn Res. 2018 Sep 3;2:18. doi: 10.1186/s41512-018-0040-7. eCollection 2018.
PubMed 31093566
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Physiological Deterioration by the SNAP40 Wearable Device Compared to Standard Monitoring Devices in the Emergency Department
- ClinicalTrials.gov ID
- NCT03179267
- Acronym / sponsor ID
- SNAP40ED / 17/SS/0028
- Conditions
- Vital Signs
- Keywords
- vital signs, monitoring, early warning score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Collaborators
- SNAP40, University of Edinburgh
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years there has been increasing focus on the earlier detection of deterioration in the clinical condition of hospital patients with the aim of instigating earlier treatment to reverse this deterioration and prevent adverse outcomes. This is especially important in the ED, a dynamic environment with large volumes of undifferentiated patients, which carries inherent patient risk. SNAP40 is an innovative medical-grade device that can be worn on the upper arm that continuously monitors patients' vital signs including relative changes in systolic blood pressure, respiratory rate, heart rate, movement, blood oxygen saturation and temperature. It uses automated risk analysis to potentially allow clinical staff to easily and quickly identify high-risk patients. The aim of this study is to investigate whether the SNAP40 device is able to identify deterioration in the vital sign physiology of an ED patient earlier than current standard monitoring and observation charting techniques.
Detailed description
As well as the potential of the SNAP40 device to improve patient safety, we believe that the SNAP40 device will increase ED efficiency, improve and increase use of resources and enable improved patient flow through the ED. Currently the only option for continuous monitoring or regular observations in the ED is to connect the patient to a standard monitor. Whilst these monitors can be portable they are not lightweight enough to allow the patient to be ambulatory within the ED and therefore require the patient to have a bed and a bed space or cubicle. This leads to lack of space within the ED, less cubicles (which allow privacy) free for performing history taking, examination and procedures, difficulty accessing patients and difficulty transporting them to areas where specialist tests can be performed (i.e. radiology and ECG). SNAP40 may remove the need for patients to be confined to beds and bed spaces (unless clinically required) freeing up space within the ED and allowing the ED care processes to occur much more freely increasing efficiency and speed of patient processing. This will undoubtedly lead to improved patient experiences around their ED and hospital journey.
The SNAP40 device also has the potential to free up resources, which can be used to improve patient care and experience in the ED. SNAP40 may reduce clinical staff time taken to record observations enabling them to provide patients with other aspects of care (i.e. analgesia and treatments) more regularly and in a timelier manner. Clinical staff may be able to spend more time with patients allowing better quality communication with them and their relatives. There will potentially be more time for traditional nursing care and personal care.
Whilst there are some other similar medical devices on the market (i.e. www.biovotion.com, www.sensium-healthcare.com, www.vitalconnect.com, http://www.caretakermedical.net) using wristbands, patches or finger cuff technology, currently none are being used in ED clinical practice.
This study will examine the SNAP40 device by comparing its performance to detect physiological deterioration against standard observations taken by clinical staff (nurses, doctors and clinical support workers) within the ED. The study will assess whether the device is able to detect physiological derangement sooner that standard monitoring devices.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Addition to standard care
| Arm | Type | Receives |
|---|---|---|
| SNAP40 monitor | Experimental | Device: SNAP40All participants in the study will be fitted with the SNAP40 ambulatory monitoring device as well as usual monitoring as standard care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participant aged 16 years or over AND
- Participant triaged to Majors (High Dependency or Immediate Care) OR Participants who are stepped down from Resuscitation room care to High Dependency or Immediate Care
Key exclusion criteria (8 listed)
- Participants under 16 years of age
- Previous participation in the study
- Participant in custody
- Participants deemed high risk for absconding by clinical staff
- Participants unable to communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNAP40SNAP40 ambulatory monitoring device | Device | SNAP40 monitor |
Primary outcome
Time to detection of deterioration
Time frame: 4 hours
Time to detection of deterioration in an ED patient's vital sign physiology defined as an increase in NEWS score. This would include a deterioration in blood pressure, pulse/heart rate, respiratory rate, skin temperature (SNAP40)/core temperature (Standard), oxygen saturation reading or movement (SNAP40)/GCS (Standard).
4 secondary outcomes
Staff observation and responding to alarm times
Time frame: 4 hours
Percentage clinical escalation of care when deterioration detected.
Time frame: 4 hours
Participants satisfaction
Time frame: 4 hours
Staff satisfaction
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Derived from this study: PubMed 31093566Reed MJ, McGrath M, Black PL, Lewis S, McCann C, Whiting S, O'Brien R, Grant A, Harrison B, Skyrme L, Odam M. Detection of physiological deterioration by the SNAP40 wearable device compared to standard monitoring devices in the emergency department: the SNAP40-ED study. Diagn Progn Res. 2018 Sep 3;2:18. doi: 10.1186/s41512-018-0040-7. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt Reed principal investigator
NHS Lothian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNAP40 in people with Vital Signs, run by NHS Lothian at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to detection of deterioration (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03179267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.