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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of the Origin Intubation System | Experimental | The Origin Intubation System will be utilized on participants undergoing general anesthesia for surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Origin Intubation System | Device | This device leverages self-deploying geometry to guide intubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall intubation duration | The time needed for intubation. | Day of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| First-pass intubation success | Ability to intubate with the device the first time of use on a given participant. | Day of surgery. |
| Overall intubation success | Whether or not the clinician is able to intubate using the Origin Intubation System. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amit Saxena | Contact | (650) 723-6411 | arsaxena@stanford.edu | |
| Samantha Gaston, B.S., B.A. | Contact | 650-714-2542 | sgaston@stanford.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30167699 | Background | Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044. | |
| 34153007 |
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| Day of surgery. |
| Adverse events | Adverse events associated with use of experimental device. | From enrollment to follow-up period. |
| User assessment of intubation | Usability of experimental device. | Day of surgery. |
| Patient assessment of intubation | Participant feedback on experimental device, if any. | Day of surgery. |
| Patient airway characteristics | Mallampati, thyromental distance, etc. | Day of surgery. |
| Background |
| Karamchandani K, Wheelwright J, Yang AL, Westphal ND, Khanna AK, Myatra SN. Emergency Airway Management Outside the Operating Room: Current Evidence and Management Strategies. Anesth Analg. 2021 Sep 1;133(3):648-662. doi: 10.1213/ANE.0000000000005644. |