This Phase I SBIR develops and tests the active Pedi ET-Clear system to clean mucus from 2.5 mm diameter neonatal endotracheal tubes with significantly reduced deleterious impact on lung function and mechanics, as compared to current methods. Actuated Medical, Inc. is an ISO 13485-certified medical device developer integrating active motion technologies into advanced medical devices. Public Health Problem: Endotracheal tubes (ETT) are placed in a patient's trachea when they are unable to breathe on their own. A major complication of an ETT is the buildup of secretions from the lungs, with a particular concern for Ventilator Acquired Pneumonia (VAP). Respiratory secretions in ETTs are estimated to impact 107,000 neonatal and 900,000 total patients annually in the U.S. The most common and fatal infection in the ICU is VAP. VAP increases ventilator days, critical care and hospital lengths of stay. To remove mucus, the ETT is suctioned with a suction catheter, potentially after being flushed with saline. Risks associated with suctioning include hypoxia (low oxygen in blood), bradycardia (low heart rate), or atelectasis (collapse of part of the lung). Suctioning is often required every 1 to 4 hours and strains the lungs of an already compromised patient. Lung volume is reduced by the suctioning and results in impaired gas exchange and potential lung collapse. Neonatal ETTs, with inner diameters as narrow as 2.5 mm, require frequent suctioning and are difficult to clean without obstructing the airway. A device is needed for cleaning neonatal tubes quickly, while minimizing the suction pressure required and maintaining volume in the patient's lungs. Phase I Hypotheses: Pedi ET-Clear Alpha prototype demonstrates superior safety (e 50% improvement in retained lung tidal volume) and superior efficacy (cleaner ETT in the same amount of time) compared to standard suction catheter in 2.5 mm ETTs. Hypothesis testing will be performed with ? = 0.05 and ? ? 0.20. Phase I Specific Aims:
Aim 1 Finalize Closed System Design and Construct Alpha-II Prototypes for Optimization Testing (Month 1 - 4).
Aim 2 Optimize Pedi ET-Clear Parameters for Rapid Mucus Removal with Minimal Effect on Lung Tidal Volume Compared to Baseline Impact of Current Suctioning Methods (Month 5 - 6).
Aim 3 Final Testing of Pedi ET-Clear Performance Compared to Standard Care with Neonatal Clinicians in Closed Ventilation Test Model (Month 6).
A patient is intubated with an endotracheal tube and connected to a ventilator when they cannot breathe on their own. Mucous builds up over time in the tube, and must be suctioned out. Neonatal endotracheal tubes, with inner diameters as narrow as 2.5 mm, require frequent suctioning and are difficult to clean without obstructing the airway. The suctioning puts additional stress on the lungs of an already compromised patient. A device for cleaning endotracheal tubes, particularly pediatric and neonatal tubes, without the negative impacts of current suctioning methods, will be of great benefit.
