VRES Study in Two Phases to Monitor Cardiac Surgical Patients Following Discharge From ICU (VRES)
|ClinicalTrials.gov Identifier: NCT02427828|
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : April 28, 2015
Failure to recognise deterioration early is a major cause of preventable deaths amongst hospital patients. The investigators wish to study whether continuous monitoring of 'vital signs' (pulse rate, breathing rate, and blood oxygen saturations) with computer modeled alerting to detect patient deteriorations can reduce cardiac arrest rate and critical care readmissions from the wards by alerting staff to clinical deteriorations more effectively than current paperbased systems.
Continuous monitoring of 'vital signs' can be achieved in two ways. Continuous monitoring of 'vital signs' has traditionally been restricted to the bedside because of the need for the patient to be connected by wires to the monitor.
More recently, advances in telemetry (wireless technology) have allowed the development of wearable devices which allow patients to mobilise freely, whilst constantly monitoring these 'vital signs'.
|Condition or disease||Intervention/treatment||Phase|
|Surgical Procedure, Unspecified||Device: Visensia Respiration Rate Estimation Service (VRES)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Continuous, Ambulatory, Non Invasive, Vital Sign Monitoring Using VRES of Cardiac Surgical Patients Following Discharge From Intensive Care. Impact on Detection of Physiological Deterioration|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||July 2014|
Active Comparator: Treatment Group
Assessment of Visensia Respiration Rate Estimation Service (product) to provide Respiration Rate from PPG signal, providing 3 vital signs (heart rate, oxygen saturation and respiration rate) to facilitate continuous Safety Index (VSI) calculation by Visensia, alongside standard routine intermittent observations (vital signs every 4 - 6 hours).
Device: Visensia Respiration Rate Estimation Service (VRES)
Medical device product to provide respiration rate from PPG signal
No Intervention: Control Group
Using standard routine intermittent observation (vital signs every 4 - 6 hours) and calculation of NEWS/MEWS scores for early detection of patient deterioration.
- Incidence of ward cardiac arrests [ Time Frame: Up to 72hours ]Duration of acute hospital stay
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427828
|Papworth Everard, Cambridgeshire, United Kingdom|
|Principal Investigator:||John Mackay||Papworth Hospital NHS Foundation Trust|