NCT07189182

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1

Timeline
12mo left

Started Sep 2026

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 27, 2026

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

May 30, 2025

Last Update Submit

April 22, 2026

Conditions

Device Usability

Keywords

IntubationGeneral AnesthesiaAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Overall intubation duration

    The time needed for intubation.

    Day of surgery.

Secondary Outcomes (6)

  • First-pass intubation success

    Day of surgery.

  • Overall intubation success

    Day of surgery.

  • Adverse events

    From enrollment to follow-up period.

  • User assessment of intubation

    Day of surgery.

  • Patient assessment of intubation

    Day of surgery.

  • +1 more secondary outcomes

Study Arms (1)

Use of the Origin Intubation System

EXPERIMENTAL

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

Device: Origin Intubation System

Interventions

Origin Intubation SystemDEVICE

This device leverages self-deploying geometry to guide intubation.

Use of the Origin Intubation System

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female subjects 18 years of age or older and less than 75.
  • English or Spanish Speaking.
  • Undergoing elective surgery requiring endotracheal intubation.
  • Use of general anesthesia.

You may not qualify if:

  • Patients with high aspiration risk.
  • Inability to provide informed consent in English or Spanish
  • Patients for whom an awake intubation is indicated and planned.
  • Patients with a history of head and neck radiation.
  • Pregnant patients.
  • Patients with BMI \>35
  • ASA 4 or higher
  • Patients who the investigator deems ineligible at the investigator's discretion.
  • Planned post-operative intubation.
  • Current incarceration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

  • 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.

    PMID: 30167699BACKGROUND

  • 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.

    PMID: 34153007BACKGROUND

Central Study Contacts

Dr. Amit Saxena

CONTACT

(650) 723-6411arsaxena@stanford.edu

Samantha Gaston, B.S., B.A.

CONTACT

650-714-2542sgaston@stanford.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 30, 2025

First Posted

September 23, 2025

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 27, 2026

Record last verified: 2025-08

Locations

US(1)