The Paediatric Refill Study (PRefill)

NCT02208817 | Completed

• 2 other identifiers: 14021MRK0076101
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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 Medical Research Council (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 the Paediatric Intensive Care Unit (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 24 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 noninvasive 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).

Conditions

Septicaemia; Deformity of Spine; Trauma

Keywords

capillary refill; paediatric early warning score; photoplethysmography

Outcome Measures

Primary Outcomes (1)

• Detect a 30% difference in measured CRT value between well children (PEWS <3, with normal perfusion) and unwell children (PEWS ≥3, with reduced perfusion).

  Exit from study; Well patients within 1-2 hours; Unwell patients after leaving PICU average 3 days

Secondary Outcomes (5)

• i.Feedback on acceptability of the device from patients, carers/parents, and healthcare professionals, and feedback on the graphical user interface (GUI) from healthcare professionals.

  on completion of feedback, 30 minutes

• ii. Correlation of automated CRT results with vital cardiovascular clinical observations and tests - both invasive and non-invasive.

  During study phase average 3 days

• iii. Correlation of automated CRT results with treatments supporting the cardiovascular and neurological system

  during study phase average 3 days

• CRT in well compared with unwell patients

  Grouped at end of study 12 months

• CRT changes with age and ethnicity in well children

  grouped at end of study 12 months

Study Arms (4)

Ill patients

Ill patients who require Paediatric Intensive Care or Paediatric High Dependency Care

Well Controls

Matched controls who are well (PEWS\<3)

Parent feedback

Feedback from parents/carers of children recruited into the PRefill study

Healthcare professionals feedback

Feedback from healthcare professionals who have cared for a child with the device on

Eligibility Criteria

• Age: 1 Month - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children will be recruited in The Queens Medical Centre, Nottingham University Hospitals NHS Trust, a teaching hospital, which has a paediatric intensive care unit (PICU).

You may qualify if:

• Children \& Young Adults
• Patients aged 1 month to 15 years with parental or legal guardian written informed consent.
• Patients groups:
• Patients who require PICU or high dependency care
• Matched controls who are well (PEWS\<3)
• Must have a realistic prospect of survival
• Parents/carers (for the interview element of the study):
• Parents/carers of children recruited into the PRefill study
• Healthcare professionals (for the interview element of the study):
• Healthcare professionals who have cared for a child with the device on

You may not qualify if:

• Children \& Young Adults
• Known pregnancy
• Underlying cardiac anomaly likely to affect perfusion,
• PEWS ≥3 (in matched well controls)
• Severe eczema/burns/other skin condition on site where CRT device needs to be positioned
• Known allergy to medical adhesive
• Parents/carers (for the interview element of the study):
• Unable to communicate despite translation services
• Healthcare professionals (for the interview element of the study)
• None

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Nottingham Univeristy Hospitals NHS Trust

Nottingham, Nottinghamshire, NG72UH, United Kingdom

Location

MeSH Terms

Conditions

Toxemia; Wounds and Injuries

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Don Sharkey, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: August 5, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 19, 2016

Record last verified: 2016-05

Locations

GB (1)