Clinical Evaluation of the Origin Intubation System
ConditionDevice Usability
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Origin Intubation System
DeviceThis device leverages self-deploying geometry to guide intubation.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Use of the Origin Intubation SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall intubation duration
The time needed for intubation.
Time frame
Day of surgery.Secondary outcomes
1
First-pass intubation success
Ability to intubate with the device the first time of use on a given participant.
Time frame
Day of surgery.2
Overall intubation success
Whether or not the clinician is able to intubate using the Origin Intubation System.
Time frame
Day of surgery.3
Adverse events
Adverse events associated with use of experimental device.
Time frame
From enrollment to follow-up period.4
User assessment of intubation
Usability of experimental device.
Time frame
Day of surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: