FloRight™ in the neonatal clinic
Our device was developed to assist neonatologists and pediatricians in pulmonary function evaluation. This is useful to evaluate the need and effect of interventions such as ventilation, bronchodilation, CPAP and medication. FloRight provides visual and quantitative information on tidal flow, tidal volume, respiration frequency and thoraco-abdominal asynchrony.
Clinicians are familiar with tidal and frequency measures from modern invasive ventilation systems. FloRight provides these measures non-invasively. FloRight additionally allows clinicians to objectively evaluate bronchopulmonary dysplasia and thoraco-abdominal asynchony, enabling distinction between obstructive causes for asynchrony and a lacking brain-diaphragm signal.
Designed with the neonate in mind
The nurse operated procedure takes 5-10 minutes and does not cause undue discomfort. This includes a 1 minute pre-measurement calibration step to register magnetic field variations and address potential interference from other systems. A baby can be monitored for a longer period if desirable. FloRight allows real-time monitoring using the mobile bedside device, as well as later review of logged plots and data on the device or any computer.
TinyFlow™ measurement vests are produced as disposable wrap arounds in a comfortable stretchy material, at sizes suitable for the full neonatal patient population. The vest design allows rapid access to the baby as needed.
Clinical utility
Respiratory conditions are a main cause of mortality and disease in newborns. Neonatologists and pediatricians view FloRight as a device that can non invasively provide much needed information in the neonatal care unit. No such patient- and user friendly device has been available to provide lung function information for neonates. Due to a lack of information, positive or negative changes in lung health may be detected late, and babies may be over- or undertreated with ventilation, CPAP or medication. It is well known that prolonged breathing assistance in neonatal intensive care can stop being helpful and instead cause serious chronic illness.
About 1 in 10 newborns are admitted to intensive care, at a cost of $3000 per day plus intervention costs. A large majority of these babies receive some form of breathing support; either invasive ventilation for the most premature or sickest babies or non-invasive respiration support such as CPAP or nasal cannula. Other than monitors linked to advanced invasive ventilators used in the sickest babies, clinicians in the neonatal care ward lack methods to assess pulmonary function. This is the case despite a recognition of pulmonary function as key information, and despite annual global spending of $1.2 billion on neonatal and perinatal monitoring, including heart rate and blood oxygen monitoring, x-rays and blood tests (LSI, 2008).
Respiratory Distress Syndrome affects nearly all neonates born before the 30th week of gestation and over 40% born at 30-32 weeks. Bronchopulmonary Dysplasia is diagnosed in over 60% born before the 26th week, declining to 3% at 30-32 weeks. Breathing interruptions (apnea) occur in 85% of infants before 34 weeks. Respiratory Syncytial Virus infects a large majority of children before age 2 including some neonatal intensive care patients. Together, these conditions represent a considerable risk of injury and death, and interference with growth and development.
Other applications
The first and perhaps most urgent clinical need for FloRight is in the neonatal care ward. FloRight also holds promise as an alternative to mask-based systems in adults, including unconscious patients and older children. We welcome parties interested in codevelopment or comarketing partnerships.