COVID-19
Conditions
Brief summary
The purpose of this study is to develop a safe, easily scalable, and simple method to split a single ventilator for use amongst two or more patients, thus serving as a capacity bridge to save patient lives until manufacturers can produce enough ventilators.
Interventions
DEVICEEmergency Ventilator Splitter
Device to enable oxygen delivery to two patients independently from a single ventilator.
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Phase I * Undergoing routine thoracic surgery which will include the use of a dual lumen endotracheal tube at Stanford. * Phase II * Able to give consent * On venovenous extracorporeal membrane oxygenation for reason other than COVID-19 * Phase III * Able to give consent * Infected with COVID-19 and will likely require mechanical ventilation.
Exclusion criteria
* Phase I * Significant cardiac comorbidities * Liver disease * Phase II * Significant cardiac comorbidities * Pre or Post-transplant patient * Infection with COVID-19 * Phase III * Co-infection with disease aside from COVID-19 * Severely ill requiring high ventilator requirements and not stable for ventilator splitting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of 1-minute test | Up to 1 minute | This outcome will measure whether the device will function for respiratory support for 1 minute (yes or no; phase 1 only) |
| Completion of 24-hour test | Up to 1 minute | This outcome will measure whether the device will function for respiratory support for 24 hours (yes or no; phase 2 only) |
Countries
United States
Outcome results
None listed