NCT03179267

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

September 25, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2017

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

June 6, 2017

Last Update Submit

April 11, 2018

Conditions

Vital Signs

Keywords

vital signsmonitoringearly warning score

Outcome Measures

Primary Outcomes (1)

  • 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).

    4 hours

Secondary Outcomes (4)

  • Staff observation and responding to alarm times

    4 hours

  • Percentage clinical escalation of care when deterioration detected.

    4 hours

  • Participants satisfaction

    4 hours

  • Staff satisfaction

    4 hours

Study Arms (1)

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

Device: SNAP40

Interventions

SNAP40DEVICE

SNAP40 ambulatory monitoring device

SNAP40 monitor

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 31093566DERIVED

Study Officials

  • Matt Reed

    NHS Lothian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Addition to standard care
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 7, 2017

Study Start

September 25, 2017

Primary Completion

December 22, 2017

Study Completion

December 22, 2017

Last Updated

April 12, 2018

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)