To design and test an EIT device and interface for infants based on a modified adult device (Continuous Regional Analysis Device for neonate Lung (CRADL) project). More specifically this protocol focusses on collecting EIT recordings in infants…
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Distribution of tidal ventilation before and after an intervention or event
that is know for its changes in regional lung aeration and the regional changes
in the right vs the left lung and the anterior vs the posterior part of the
lung.
Secondary outcome
The relationship and timing of EIT changes compared with onset of
intervention/event or the results from other diagnostic tools will be explored.
Background summary
Both the primary disease state and the effect of clinical interventions can
cause heterogeneous lung disease in neonatal and pediatric intensive care
patients. This heterogeneity can compromise lung function and lead to long
lasting pulmonary morbidity. There are currently no bedside imaging tools to
monitor changes in (regional) lung aeration mainly expressed as distribution of
tidal ventilation. Electrical Impedance Tomography (EIT) is a promising
non-invasive, radiation-free, bedside applicable, monitoring tool for measuring
regional changes in lung aeration. EIT has been extensively studied in infants,
showing that EIT is feasible and safe in this vulnerable population. However,
clinical implementation has been hampered by the lack of an easy to use patient
interface, real-time display of EIT recordings, and clinically relevant EIT
measures. In the adult population these shortcomings hev been solved and EIT
has now entered the clinical arena.
Study objective
To design and test an EIT device and interface for infants based on a modified
adult device (Continuous Regional Analysis Device for neonate Lung (CRADL)
project). More specifically this protocol focusses on collecting EIT recordings
in infants needing respiratory support for (imminent) respiratory failure in
the intensive care unit.
Study design
This is an observational study
Study burden and risks
The results of this study will have no direct benefit to the patient because it
is purely observational and the EIT recordings are not available for guiding
care. EIT has been used in hundreds of (preterm) infants and is considered a
safe and non-invasive monitoring technique. The risk and burden for the patient
are therefore considered negligible. This study needs to be conducted in
infants because this is the target group for the new EIT device. In adults, the
EIT device is already available and implemented in daily clinical care.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Age less than 7 years (limited by available electrode belt sizes)
Admitted to the NICU or the PICU
At high risk of or developing respiratory failure for which respiratory support is needed
Written informed consent from both parents or legal representatives
Exclusion criteria
Postmenstrual age < 25 weeks
Birth weight < 600 g
Electrical active implant
Chest skin lesions preventing placement of electrode belt
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58171.018.16 |