Device Usability
Conditions
Keywords
Intubation, General Anesthesia, Anesthesia
Brief summary
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.
Detailed description
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).
Interventions
DEVICEOrigin Intubation System
This device leverages self-deploying geometry to guide intubation.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or Female subjects 18 years of age or older and less than 75. 2. English or Spanish Speaking. 3. Undergoing elective surgery requiring endotracheal intubation. 4. Use of general anesthesia.
Exclusion criteria
1. Patients with high aspiration risk. 2. Inability to provide informed consent in English or Spanish 3. Patients for whom an awake intubation is indicated and planned. 4. Patients with a history of head and neck radiation. 5. Pregnant patients. 6. Patients with BMI \>35 7. ASA 4 or higher 8. Patients who the investigator deems ineligible at the investigator's discretion. 9. Planned post-operative intubation. 10. Current incarceration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall intubation duration | Day of surgery. | The time needed for intubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First-pass intubation success | Day of surgery. | Ability to intubate with the device the first time of use on a given participant. |
| Overall intubation success | Day of surgery. | Whether or not the clinician is able to intubate using the Origin Intubation System. |
| Adverse events | From enrollment to follow-up period. | Adverse events associated with use of experimental device. |
| User assessment of intubation | Day of surgery. | Usability of experimental device. |
| Patient assessment of intubation | Day of surgery. | Participant feedback on experimental device, if any. |
| Patient airway characteristics | Day of surgery. | Mallampati, thyromental distance, etc. |
Countries
United States
Contacts
CONTACTDr. Amit Saxena
CONTACTSamantha Gaston, B.S., B.A.
Outcome results
None listed