confirming proper positioning for endotracheal tubes, especially for high-risk pediatric patients
An endotracheal tube (ETT) is a flexible plastic tube placed through the mouth or nose into the trachea to help a sedated patient breathe while on a mechanical ventilator. Improper positioning of ETTs is associated with significant morbidity and mortality, particularly in vulnerable populations such as critically ill infants and young children. Proper positioning is commonly confirmed with a chest radiograph (CXR). However, CXRs are associated with significant time and cost to the hospital, are not always readily available and can contribute to serious and largely preventable health issues later in life due to cumulative radiation exposure.
University of Michigan’s John Charpie, M.D., Ph.D., has developed an ultrasound-detectable ETT device ideal for use in the pediatric population, which will provide rapid, real-time confirmation of placement, reduce hospital costs, and most importantly, reduce the risks to the intubated patient.
“Once the technology is developed for the pediatric population, which is the most difficult population and device-size to manufacture, it can readily be scaled up to include all sizes of devices for use in all patient populations,” explains Charpie. “The ultrasound-detectable endotracheal tube (USD ETT) will allow clinicians to confirm appropriate device placement in a number of situations where it is currently not able to be confirmed. This will offer all clinicians a safer and more cost-effective alternative in every clinical setting.”
Significant Need
Cuffed ETTs, designed to provide a seal within the airway that allows airflow through the ETT but prevents air or fluids passing around the ETT, are visible by ultrasound for gross confirmation of intra-tracheal position. However, as currently designed, ETTs do not meet the necessary clinical requirements for accurate and precise depth position location in neonates and infants. Additionally, real-time confirmation is not generally available because there is often a significant delay to obtain a portable, bedside CXR (if available) and often a need for repeat testing, causing unnecessary time to care, costs to the hospital, and risks to the intubated patient.
Compelling Science
The ultrasound-detectable endotracheal tube can be used anytime a patient requires a cuffed ETT, which occurs in most cases. The USD ETT is placed by direct or indirect laryngoscopy, and the cuff is inflated in the same way as current devices. The USD ETT will also include a radiopaque marker identical to existing devices on the market so that CXR can still view them using standard practices. The subtle, yet impactful, design change lies in the shape of the ETT cuff itself. Most high-volume, low-pressure cuffs are round or oblong. The USD ETT cuff will have overall similar dimensions to the current cuffs with a slight divot in the middle of the cuff. This divot allows the clinician to accurately image the ETT position with ultrasound.
Competitive Advantage
Clinicians using the USD ETT will not have to change their current behavior or receive any new training for ETT placement, although minimal training may be required to interpret the ultrasound images. The USD ETT will also be radiographic and will be able to be visualized using the traditional CXR method, if necessary. Once placed, the USD ETT can be viewed immediately at the bedside of the patient by the clinician. If placement is not correct, the ETT may be repositioned while viewed by the ultrasound in real time. Real-time confirmation is not available with CXR, and there is often a significant delay to obtain a portable, bedside CXR.
While other device studies focus on using ETT with adult populations, the USD ETT can provide the resolution necessary for children and neonates. With the added imaging modality, the use cases for checking appropriate ETT placement expand to operating rooms, pre-clinical settings, obstetric practices, intensive care units, emergency rooms, and during cardiac arrest where CXR technology may not be immediately available or appropriate for clinical use.
Overall Commercialization
- Intellectual Property: Patent application filed.
- Commercialization Strategy: Develop the device and regulatory documentation in support of a clinical trial. Obtain follow-on funding.
- Regulatory Pathway: Create the DHF documentation package (per 21 CFR 820.30) in support of the IRB, IDE, and eventual 510(k) submissions. Clinical trial is in progress.
- Engage Investors: License device and/or form start-up company.
- Product Launch Strategy: Submission to IRB and FDA Investigational Device Exemption.
Milestones
- Sterilization validation complete
- Shelf life and conditioning complete
- Packaging and distribution complete
- All verification testing complete and documentation ready for IRB and FDA submission
- Submission to IRB and FDA IDE in progress
