Severe respiratory disease is one of the leading causes of infant illness and death worldwide. There is a significant upward trend of clinical infant respiratory studies, including the investigation into respiratory success in ventilated infants, SIDS, and neurological disorders that affect the normal respiratory pattern. In this article, we discuss how noninvasive respiratory monitoring and VivoSense® software helps researchers collect and analyze respiratory data for clinical studies focused on infant and neo-natal breathing patterns.
Recommended Respiratory Data Collection Method
Researchers and the American Academy of Sleep Medicine recommend using respiratory inductance plethysmography (RIP) to collect respiratory data for infants because it is noninvasive and not effort dependent.1 RIP is a sensor technology that measures the independent respiratory waveforms of the rib cage and abdomen from which pulmonary metrics, including volume and respiratory events, may be derived. RIP monitoring can also produce data that airflow sensors cannot, related to analyzing individual rib cage and abdominal band respiratory movements and the coordination of the diaphragm in breathing.
Another way to measure airflow and ventilation is to use an airflow sensor. The challenge with this approach is that these sensors aren’t practical for infants to wear long-term. They obstruct the infant’s face and prevent normal eating and sleeping activity.
The Advancement of RIP
RIP is becoming more prominent as a diagnostic tool as well as a tool to discover unique respiratory diagnostic indexes. The market for respiratory monitoring is on the rise and expected to increase to $8.5 billion globally by 2021, showing an average annual increase of 3.6%. Monitoring respiratory technologies are shifting to more user-friendly devices that allow expansion into the home segment, including RIP technology for clinical studies.2
An Example of RIP Used in a Pediatric Sleep Apnea Study
Quantitative Analysis of Thoracoabdominal Asynchrony in Pediatric Polysomnography by Nemours duPont Hospital for Children.
This 2016 study aimed to determine if the average phase angle (the measure of the relationship between the chest and abdominal respiratory volume waveform), measured with RP, correlates to the obstructive apnea index in children with current respiratory sleep issues. With the help of VivoSense® Wearable Sensor Data Visualization and Analytics Software, they found that the average phase angle (APA) has a significant positive correlation with obstructive apnea index. This correlation could make APA a clinical indicator of obstructive sleep apnea, in combination with other established indicators.
Analyzing and Visualizing Data with VivoSense®
Many clinical trials use VivoSense® software to analyze and isolate specific metrics from the raw RIP data. It’s at the forefront of establishing RIP respiratory monitoring as a reliable endpoint for clinical trials. The software is currently being used in active respiratory clinical trials monitoring and data analysis in 3 Phase II Clinical Trials, with customers including Biogen and F. Hoffmann-La Roche Ltd.