The Paediatric Refill Study (PRefill)
Condition: Septicaemia; Deformity of Spine; Trauma
MeSH terms: Sepsis
Study type: Observational

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).
    

Detailed description: 
      Following recruitment, patients will have two devices placed on their skin, one on a limb
      (e.g. forearm), and one on their chest. They will be fixed to the skin using medical adhesive
      tape. The devices will be left on for around 1 hour on the "well patients" who are on a
      general paediatric ward. At the end of this time a member of the research team will remove
      the devices.

      For patients going to the paediatric intensive care unit (PICU) the devices will be used to
      gather the CRT data before admission (where possible), during and following discharge from
      the PICU. The PICU participants will have the device left on during their stay, with the
      agreement of the clinical team caring for the patient, with the device being resited every
      4-6 hours as is normal practice for medical devices attached to the skin. Data will be
      collected in this way during the PICU stay (which is typically 2-3 days) or until the patient
      is transferred to the general ward. Before they go home, these participants will be monitored
      again for up to an hour with the CRT devices to obtain data when they are well.

      Collecting data in this way should allow us to show that our CRT device can detect a 30%
      difference in perfusion between the well and the unwell patient. By comparing well patient to
      unwell patient, and by comparing unwell patient, with themselves when well. For each
      participant we will collect routine demographic details, medical history details, Fitzpatrick
      skin colour assessment (that is their skin tone according to a recognised scale), height,
      weight and vital signs. Where taken, we will collect clinically relevant data in relation to
      the treatment received and results of clinical investigations for correlation with our device
      data. Patients on the PICU will have noninvasive measures of perfusion performed by the
      clinical team. The research team will also perform these at agreed times suitable to the care
      of the patient. This will include capillary refill and ultrasound assessment of blood flow
      (cardiac output).

      We will also conduct a semistructured interview with the patient and/or their parents/carer
      at the time of the study to gain feedback on the device. This should take about 15 minutes
      and will take the form of a semistructured interview. We will also seek user (i.e. healthcare
      professionals) feedback on the device and the accompanying GUI using a semistructured
      interview (approximately 15 minutes).
    

Observational model: Case-Control
Time perspective: Prospective
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).
      
Keywords: capillary refill; paediatric early warning score; photoplethysmography