The purpose of this study is to evaluate the airway detection performance of the Entarik Feeding Tube System, and to collect data when the Entarik Feeding Tube is in the Airway for device development.
The study is a prospective, single center, non-blinded, single arm study. Subjects who are scheduled to undergo an elective bronchoscopy procedure will have an Entarik Feeding Tube placed into the airway through an endotracheal tube under direct visualization while temperature and impedance data are collected by the Entarik monitor. Other data will be passively simultaneously collected through the Feeding Tube.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
30
Tube will be inserted into the trachea to make airway data measurements.
Temple University Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGPercentage of accurate airway verifications by the Entarik feeding tube system
Percentage of accurate verifications of airway placement of the tip of the Entarik feeding tube at the Safety Check Depth.
Time frame: During the airway placement procedure
Incidence of Adverse Events
Incidence of adverse events: (a) related to placement and (b) throughout the duration of the presence of the feeding tube within the subject.
Time frame: During the airway placement procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.