Feasibility of wireless cardio-respiratory monitoring with a belt in preterm infants

In preterm infants, heart rate, ECG and respiration monitoring is performed
using adhesive electrodes. These electrodes can damage the skin, and the wires
they are attached to impede parent-infant interaction. These problems may be
solved by a non-adhesive, wireless belt able to perform cardiorespiratory
monitoring in neonates. Such a belt is currently being developed by Bambi
Medical B.V. The belt uses the technique of diaphragmatic electromyography
(dEMG) to accomplish cardiorespiratory monitoring, a recently introduced (via
adhesive electrodes) monitoring technique in the neonatal intensive care unit
(NICU), because it has the potential to improve respiratory and apnea
monitoring over traditional chest impedance (CI) monitoring, by providing
direct insight in breathing effort of the infant. dEMG monitoring might guide
the optimal choice of respiratory support. It can provide both a heart rate,
ECG, and respiratory rate and as such this technique could potentially replace
CI monitoring. However, to date the feasibility of obtaining a dEMG signal with
a belt has not been studied.

The objective of this explorative study is to determine the feasibility of
measuring dEMG with a belt in preterm and term born infants during routine
caregiving. Feasibility is confirmed when heart rate and respiratory rate reach
a predefined level of agreement between the wireless belt and standard
electrode monitoring.

Prospective observational study design

The results of this study will have no direct benefit to the patient because
the study is observational. The dEMG recordings are not available for guiding
care. This is a non-invasive, observational study in which infants will wear an
additional monitoring device with a minimal risk of skin irritation. This study
needs to be conducted in infants, since this is the population of intended use
for the new monitoring device.