Stanford University
Stanford, California, 94305, United States
NCT Number: NCT07189182
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Early Phase 1
Stanford, California, 94305, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This device leverages self-deploying geometry to guide intubation.
Time frame: Day of surgery.
The time needed for intubation.
Time frame: Day of surgery.
Ability to intubate with the device the first time of use on a given participant.
Time frame: Day of surgery.
Whether or not the clinician is able to intubate using the Origin Intubation System.
Time frame: From enrollment to follow-up period.
Adverse events associated with use of experimental device.
Time frame: Day of surgery.
Usability of experimental device.
Time frame: Day of surgery.
Participant feedback on experimental device, if any.
Time frame: Day of surgery.
Mallampati, thyromental distance, etc.
Contact information is provided by the study sponsor or research team.
Dr. Amit Saxena
CONTACT
Samantha Gaston, B.S., B.A.
CONTACT
Stanford University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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