PNEUMACRIT V1.0
Research type
Research Study
Full title
PNEUMACRIT (Preterm Neonate / neonatal Embedded Universal Microelectronic wearable Acquisition for Cardio Respiratory Intensive Therapy)
IRAS ID
286908
Contact name
Neil Patel
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
This is a feasibility study to optimise and develop a prototype for a new technology incorporating Electrical Impedance Tomography, or EIT, to assess lung function (breathing) in infants who are receiving intensive care.
Lung disease is the commonest cause of admission to neonatal intensive care units (NICUs), however, there are no existing tests to allow doctors to assess which areas of the lungs are well inflated or not (also called lung recruitment). EIT technology allows non-invasive assessment of lung function by placing a fabric belt containing electrical sensors around the patient's chest. As the patient breaths, the EIT device calculates lung recruitment in all areas of the lung. Such improved assessment of lung recruitment can help doctors reduce the risk of long-term lung damage.
This study will assess a prototype EIT system for infants developed by biomedical engineers from Middlesex University and University of Cambridge and the clinical team at the Royal Hospital for Children Glasgow.We will approach the families of up to forty infants in the NICU and ask them to consent to take part. The Oulu University Hospital in Finland will also recruit further subjects as part of this study, but it will have a separate sponsorship.
Each participating infant will wear the EIT belt for up to 24 hours, alongside their normal care. We will collect the EIT sensor data, assess the comfort of the EIT belt for the patient, and obtain views of their families and the clinical team. We will use this information to improve the EIT prototype.
We will only include infants if their doctors agree they are well enough to take part. No EIT data will be used clinically or impact care of patient.
Lastly, anonymised device data collected from Glasgow and Oulu will be combined to carry out the analysis.REC name
HSC REC B
REC reference
22/NI/0027
Date of REC Opinion
15 Feb 2022
REC opinion
Favourable Opinion