A Non-Interventional Blinded Observational Pilot study to evaluate Edi metrics to better predict extubation readiness

Brief description of study

The purpose of this research study is to evaluate Edi signals and metrics to see if we can better predict extubation readiness. The Edi catheter is a tube that is inserted from the nose/mouth and continues to the stomach. Typically, this is referred to as a nasogastric or an orogastric tube and is used for nutrition or stomach decompression in infants who are unable to feed by mouth independently. The Edi catheter is used the same way the a regular Nasogastric or orogastric tube, but it is also able to monitor electrical activity of the diaphragm during respiration. The aim of this study is to evaluate the Edi signals and metrics to see if we can better predict if the infant is ready for extubation, meaning the breathing tube is ready to be taken out, and avoid the need for reintubation after extubation. It is standard of care to use infant’s clinical status along with ventilator settings and lab values to determine if the infant is ready for extubation. This is still what will be done on any study participant. The signals will be evaluated after clinical decisions are made and will not interfere with standard of care.

Clinical Study Identifier: s21-01071

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