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Continuous Regional Analysis Device for neonate Lung

Periodic Reporting for period 2 - CRADL (Continuous Regional Analysis Device for neonate Lung)

Reporting period: 2017-07-01 to 2019-06-30

The overarching objectives of CRADL are:

1) To deliver a tool that provides continuous, non-invasive, radiation free, bedside information on regional lung aeration and ventilation during daily clinical care of (preterm) infants and children with respiratory failure.
2) To assess the effectiveness, efficacy and safety of such a system in guiding respiratory management and supportive care of the most common causes of paediatric respiratory failure (respiratory distress syndrome,
bronchiolitis and acute respiratory distress syndrome), with the final goal to reduce short and long term adverse effects of disease and its treatment in this population.

key results:

1) The multicentre clinical CRADL study accomplished within WP1 generated the largest database of clinical EIT data in the world equalling to approximately 1.9 billion of primary EIT images (about 437 days of data
acquired at a sampling rate of 49 images/s)
2) With 200 patients included, the CRADL study is one of the largest clinical studies ever carried out.
3) The CRADL study is the first clinical study using EIT technology where study participants were examined during routine clinical care. No study-related interventions were performed meaning that the current results
reflect for the first time the unbiased potential benefit of EIT monitoring in critically ill neonatal and paediatric patients.
4) In spite of the fact that the examinations were conducted during routine care, we could demonstrate that skin contact impedance, essential for reliable generation of EIT images, was sufficient during 85% of individual
examination times.
5) In contrast to all earlier EIT studies, in which the patients were typically examined by EIT only during short periods of time (below one hour), the CRADL study participants were continuously monitored by EIT for up to
three days.
6) Although EIT is generally accepted to be a non-invasive and non-harmful medical technology and no adverse events associated with this technology were described in previous studies performed in neonates, infants and
children only the CRADL study provided the evidence that the use of EIT is safe in this very fragile patient population even during long-term monitoring.
7) The data generated in WP1 provided important patient case data that were implemented as case scenarios during the development and testing of the neonatal/paediatric Graphical User Interface developed in WP2.
8) The clinical CRADL EIT data was essential for the progress in WP5 where it was used for instance in the development of the breath detection algorithm. Since the breathing pattern of preterm and term neonates is
extremely variable, regarding the respiratory rate, tidal volume and the incidence of apnoeas, the newly developed evaluation algorithms were essential for the successful completion of the CRADL data analyses. These
novel breath-detection algorithms are highly relevant for the future clinical use of EIT in neonatal patients.
9) The EIT data acquired in the CRADL study was also utilized in the development of other EIT evaluation algorithms (which are described within WP4), aiming at the assessment of regional lung ventilation behaviour.
10) The patient examinations conducted during the CRADL study generated important inputs for further optimisation of the technology, leading for instance to a new design of the EIT electrode belts for neonates.
11) EIT was shown to detect changes in ventilation homogeneity in response to a variety of nursing and medical interventions in the CRADL study, like posture change, suctioning, administration of surfactant, change in
invasive to non-invasive ventilation (and vice versa), etc. The main EIT measures calculated to analyse these changes in ventilation distribution were the global inhomogeneity index, coefficient of variation and the
centre of ventilation.
12) The CRADL clinical study could also demonstrate the capacity of EIT to detect adverse events, like pneumothorax, atel
The main results of the work carried out since the beginning of the project to the end of the first reporting period are:

- Recruited patients
- Set the desired parameters for the neonates
- Created a prototype system
- Modified an adult system and used it to successfully recruit data from patients
- We have been able to monitor patients over a 72 hour period
- Defined & validated the clinical paramenters
- Created a shared database with the results
- Managed to recruit associate partners to the study
Since the beginning of the project, progress made beyond the state of the art are that we have deveThe main loped:

- A new breath detection algorythim
- New hardware
- Shape detection

We haven't changed the impacts listed in the Grant Agreement below - they are still applicable.

Project wide impacts

1. The novel system will provide a valuable clinical tool to monitor function and control of breathing indices (including measures of breathing pattern, lung volume, ventilation inhomogeneity and regional distribution of ventilation.
2. The non-intrusive nature of the instrument means that lung function can be monitored continuously, on-line in routine clinical monitoring without causing unnecessary discomfort to neonates/predicates.
3. A novel device for other EIT applications both medical (brain, breast etc) and process tomography.
4. The analogue building blocks will be key components for the development of other high-performance integrated biomedical systems, for example, neural sensory systems and lab-on-a-chip for bio-assays.
5. Become a key system for all clinical departments in the world.

The project offers the potential to significantly reduce the cost of patient care, reduce the mortality and allow systematic monitoring of the neonate function. The development of this urgently needed system will greatly
contribute towards improving further the standing of the EU’s bioelectronics industry.
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