Paediatric Refill (PRefill) Study
Research type
Research Study
Full title
Development of a Novel Paediatric Continuous Early Warning (PaedCEW) Monitor for Children at Risk of Respiratory and Cardiovascular Collapse - The Paediatric Refill (PRefill) Study
IRAS ID
144770
Contact name
Don Sharkey
Contact email
Sponsor organisation
University of Nottingham
Research summary
2 recent national reports ’Why Children Die’ and ’Are we there yet?’identified
deficiencies in recognising and managing sick children. Key recommendations from both
reviews included the development and adoption of ‘track and trigger’ or a paediatric early warning score (PEWS) to better identify the sick or deteriorating child.
PEWS tools offer the potential to identify and respond sooner to clinical deterioration. Capillary refill time (CRT) is a measure of skin blood flow and is a vital part of many early warning and resuscitation scores. It is a sensitive marker of infection and dehydration in children. However, due to how it is performed and interpreted CRT is prone to marked variability between observers.
We have MRC funding to develop an automated capillary refill device and user interface to provide a paediatric continuous early warning (PaedCEW) monitoring system. The PaedCEW system would complement and support current clinical practice and aim to address the difficulties of recognising ill children.
We aim to recruit 20 ill children (on PICU) with 2 matched controls without significant illness from the Nottingham Children’s Hospital.The 20 ill children will have their CRT (and PaedCEW score) monitored before, during and after admission to PICU. This will allow correlation with invasive (BP, central venous oxygen saturations, lactate) and noninvasive (CRT, heart rate, cardiac output) measures of cardiovascular status during periods of stability and compromise. Matched controls will be monitored for around 2-4 hours. This pilot study will allow development of our system.
This is a proof of concept study. This study aims to demonstrate a novel device for measuring CRT. Its correlation with non-invasive measures of cardiovascular status will enable a pragmatic comparison with current clinical practice. In addition, correlation with invasive measures of cardiovascular status will enable us to calculate sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV).REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/0119
Date of REC Opinion
15 Apr 2014
REC opinion
Favourable Opinion