Not provided
Not provided
Not provided
Not provided
Not provided
Different approach to be taken for the device.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Routine surgery | Experimental | As part of routine cardio-thoracic surgery, endotracheal tubes split from ventilator delivering oxygen independently to each lung for up to 1 minute. |
|
| Phase 2: ECHO treatment | Experimental | During care with Extracorporeal Membrane Oxygenation (ECMO) for non-SARS-CoV-2, endotracheal tubes split from ventilator delivering oxygen independently to each lung for up to 24 hours. |
|
| Phase 3: COVID-19 treatment | Experimental | Endotracheal tubes split from ventilator delivering oxygen independently to two patients with COVID-19 disease for up to 1 hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergency Ventilator Splitter | Device | Device to enable oxygen delivery to two patients independently from a single ventilator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion of 1-minute test | This outcome will measure whether the device will function for respiratory support for 1 minute (yes or no; phase 1 only) | Up to 1 minute |
| Completion of 24-hour test | This outcome will measure whether the device will function for respiratory support for 24 hours (yes or no; phase 2 only) | Up to 1 minute |
| Completion of 24-hour test | This outcome will measure whether the device will function for respiratory support for 1 hour (yes or no; phase 3 only) | Up to 1 hour |
Not provided
Not provided
Inclusion Criteria:
Phase I
Phase II
Phase III
Exclusion Criteria:
Phase I
Phase II
Phase III
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joseph Woo, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94304 | United States |
No plan to share data.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |