Vital Signs Clinical Trial
— SNAP40EDOfficial title:
Detection of Physiological Deterioration by the SNAP40 Wearable Device Compared to Standard Monitoring Devices in the Emergency Department
Verified date | April 2017 |
Source | NHS Lothian |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | December 22, 2017 |
Est. primary completion date | December 22, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: 1. Participant aged 16 years or over AND 2. 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 Exclusion Criteria: 1. Participants under 16 years of age 2. Previous participation in the study 3. Participant in custody 4. Participants deemed high risk for absconding by clinical staff 5. Participants unable to communicate in English 6. 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 7. Patients with implantable defibrillators, pacemakers or neurostimulators will be excluded 8. 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | Midlothian |
Lead Sponsor | Collaborator |
---|---|
NHS Lothian | SNAP40, University of Edinburgh |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Staff observation and responding to alarm times | Time ED staff spend performing a charting observations and responding to standard monitoring alarms. | 4 hours | |
Secondary | Percentage clinical escalation of care when deterioration detected. | Percentage clinical escalation of care when deterioration detected. | 4 hours | |
Secondary | Participants satisfaction | Participants rating of experience of both SNAP40 and current monitoring. | 4 hours | |
Secondary | Staff satisfaction | ED staff rating of experience of both SNAP40 and current monitoring. | 4 hours |
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