Department of Bioengineering
NOTE: The information on this page has been redacted to preserve potential intellectual property. Sensitive information is not being shared publicly at this time. If you have any questions or would like any additional information on this project please feel free to contact the design course instructors at Cassandra.email@example.com or Steven.Lammers@cuanschutz.edu.
Intubation is a common procedure used to secure a patient’s airway in emergent and non-emergent situations. Intubation difficulty is increased when patients have airway-narrowing obstacles - this difficulty is especially critical in pediatric patients who already have narrower airways.
If attempted intubation is not achieved in emergent situations, a tracheostomy is used to surgically secure the patient's airway. Compared to standard intubation, tracheostomy presents a significantly higher complication rate and mortality risk to patients. Therefore, there is a need for a method to reduce the difficulty of pediatric intubation associated with airway obstacles to prevent the need for tracheostomy for airway access.
After observing intubations and discussing this need with pediatric practitioners, user needs and design requirements were defined for a method to intubate difficult pediatric airways using a variable-size endotracheal tube (VSET). The selected VSET design is handled in the same way standard endotracheal tubes are during intubation. During the verification tests that followed fabrication, the VSET demonstrated significant changes in size within relevant clinical parameters. During validation testing, the VSET demonstrated excellent usability, receiving a systems usability score of 90 following a trained practitioner use test with an intubation simulation mannequin.
The similarity between the VSET and standard endotracheal tubes makes it easy for practitioners to use the VSET with little additional training and without increasing intubation procedural time. Overall, the device met user needs. Additional avenues of device development are being considered, including intellectual property protection and manufacturing methods. This device has the potential to reduce patient complication rates and mortality risk as well as reduce the long-term cost of care versus invasive airway securement measures like tracheostomy.