Emergency Ventilator Splitting Between Two or More Patients (COVID-19)

Study Overview
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Brief Summary
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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.

Official Title
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Emergency Ventilator Splitting Between Two or More Patients Using a Single Ventilator to Address Critical Ventilator Shortages During a Pandemic

Conditions
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COVID-19

Intervention / Treatment
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* Device: Emergency Ventilator Splitter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1: Routine surgery<br>As part of routine cardio-thoracic surgery, endotracheal tubes split from ventilator delivering oxygen independently to each lung for up to 1 minute. | Device: Emergency Ventilator Splitter<br>* Device to enable oxygen delivery to two patients independently from a single ventilator.<br>|
| Experimental: Phase 2: ECHO treatment<br>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. | Device: Emergency Ventilator Splitter<br>* Device to enable oxygen delivery to two patients independently from a single ventilator.<br>|
| Experimental: Phase 3: COVID-19 treatment<br>Endotracheal tubes split from ventilator delivering oxygen independently to two patients with COVID-19 disease for up to 1 hour. | Device: Emergency Ventilator Splitter<br>* Device to enable oxygen delivery to two patients independently from a single ventilator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |