There are currently two options that are utilized are artificial airways in the operating room as well in emergency medicine: the endotracheal tube and the supraglottic airway. However, with these devices, healthcare professionals often experience difficulty and/or failure in utilizing these devices during their first-pass at intubation. Additionally, military medics often forego intubation in favor of basic life support during prolonged resuscitation. This study aims to test a device, one that has been tested in over 100 cadavers, to determine if it is a viable and safer/more successful option for intubation.
While previous attempts to address the challenge of airway management involve improved visualization tools (still requiring advanced anatomical knowledge), the focus of this clinical study is to evaluate the performance of the Origin Intubation System, which leverages self-deploying geometry to guide intubation. The enabling technology is vine-inspired tip-growth, in which a soft tube extends from its tip into potentially complex shapes, driven only by a low internal air pressure. This paradigm enables a novel device design that aids in intubation through semi-self-navigation, which is resilient to difficult visualization or user skill, is significantly less traumatic compared to existing methods; and fast (because it does not require the user to identify and navigate the internal anatomy).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
15
This device leverages self-deploying geometry to guide intubation.
Stanford University
Stanford, California, United States
Overall intubation duration
The time needed for intubation.
Time frame: Day of surgery.
First-pass intubation success
Ability to intubate with the device the first time of use on a given participant.
Time frame: Day of surgery.
Overall intubation success
Whether or not the clinician is able to intubate using the Origin Intubation System.
Time frame: Day of surgery.
Adverse events
Adverse events associated with use of experimental device.
Time frame: From enrollment to follow-up period.
User assessment of intubation
Usability of experimental device.
Time frame: Day of surgery.
Patient assessment of intubation
Participant feedback on experimental device, if any.
Time frame: Day of surgery.
Patient airway characteristics
Mallampati, thyromental distance, etc.
Time frame: Day of surgery.
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