Clinical Evaluation of the Origin Intubation System

Stanford University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Device Usability

Treatments: Device: Origin Intubation System

Study type: Interventional

Funder types: Other

Identifiers

NCT07189182

80068

Details and patient eligibility

About

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.

Full 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).

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Use of the Origin Intubation System

Experimental group

Description:

The Origin Intubation System will be utilized on participants undergoing general anesthesia for surgery.

Treatment:

Device: Origin Intubation System