Origin Intubation System for Device Usability

DA
SG
Overseen BySamantha Gaston, B.S., B.A.
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Origin Intubation System to determine if it simplifies and enhances the safety of assisting patients with breathing during surgery. Traditional methods can be challenging and occasionally fail, prompting this study to seek a better solution. The trial targets individuals undergoing surgery with general anesthesia who require a breathing tube. Those planning surgery and needing intubation might be suitable candidates for this study. As an Early Phase 1 trial, participants may be among the first to experience this innovative device, contributing to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that the Origin Intubation System is safe for intubation?

Research has shown that the Origin Intubation System has been tested on over 100 bodies donated for study. This testing demonstrates that the device can be used safely in controlled environments. However, since this trial is in the early stages, information about its use in people remains limited. Early trials typically aim to understand how a treatment works and whether it can be used without major issues. Although clear information on side effects in people is not yet available, this phase of the study focuses on identifying any serious safety concerns. If the device were unsafe, it would not have reached this stage of testing.12345

Why are researchers excited about this trial?

Researchers are excited about the Origin Intubation System because it offers a new approach to intubation during surgery. Unlike traditional methods that can be cumbersome and require multiple tools, the Origin Intubation System streamlines the process with an integrated design, aiming to make the procedure safer and faster. This system could potentially reduce the risk of complications and improve patient outcomes, making it a promising advancement in surgical care.

What evidence suggests that the Origin Intubation System is effective for intubation?

Research shows that the Origin Intubation System is designed to make intubations safer and more successful. This device guides the tube into the airway with a special shape that automatically positions itself. Tests on over 100 bodies donated for research have been conducted. Early results suggest it might outperform traditional methods, which often struggle to succeed on the first try. Although limited data exists from tests on living people, the positive results from these tests suggest that this system could be a safer choice for doctors in both operating rooms and emergency situations. The device aims to simplify intubations and reduce the risk of complications. Participants in this trial will use the Origin Intubation System to assess its usability during general anesthesia for surgery.12367

Are You a Good Fit for This Trial?

This trial is for healthcare professionals who often face challenges with current intubation devices like endotracheal tubes and supraglottic airways, especially during first attempts. It's also relevant for military medics who may opt for basic life support over intubation.

Inclusion Criteria

I am between 18 and 75 years old.
I speak English or Spanish.
I am scheduled for surgery that will require a breathing tube.
See 1 more

Exclusion Criteria

Patients with high aspiration risk
Patients who the investigator deems ineligible at the investigator's discretion
My BMI is over 35.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

The Origin Intubation System is utilized on participants undergoing general anesthesia for surgery

Day of surgery
1 visit (in-person)

Follow-up

Participants are monitored for adverse events and overall intubation success

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Origin Intubation System
Trial Overview The study is evaluating the Origin Intubation System, a new device designed to improve the success rate and safety of intubations. This system has been tested in over 100 cadavers before being trialed in live scenarios.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Use of the Origin Intubation SystemExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

Clinical Evaluation of the Origin Intubation SystemThis device leverages self-deploying geometry to guide intubation. What is the study measuring? Primary Outcome Measures ...
Origin Intubation System for Improved Airway ManagementResearchers will evaluate how well the device works, focusing on its ability to safely and effectively place the tube in the airway. The study is interventional ...
Origin Intubation System for Device UsabilityTrial Overview The study is evaluating the Origin Intubation System, a new device designed to improve the success rate and safety of intubations. This system ...
Usability Assessment of an Innovative Device in Infusion ...Usability evaluation is intended to provide information about the medical devices' effectiveness and efficiency, as well as end-users' ...
Real-Time Intubation and Ventilation FeedbackThese devices help to obtain accurate feedback on ventilation and intubation quality and to perfect and tailor individual techniques. Several ...
A soft robotic device for rapid and self-guided intubationSuch efforts seek to develop a device that has the potential to benefit emergency intubation, enabling safe, rapid, and reliable intubations ...
Quality and safety in prehospital airway managementPrehospital airway management remains crucial with regard to the quality and safety of emergency medical service (EMS) systems worldwide.
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