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

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Device Feasibility
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1: Routine surgery 		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
    Device to enable oxygen delivery to two patients independently from a single ventilator.
Experimental
Phase 2: ECHO treatment 		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
    Device to enable oxygen delivery to two patients independently from a single ventilator.
Experimental
Phase 3: COVID-19 treatment 		Endotracheal tubes split from ventilator delivering oxygen independently to two patients with COVID-19 disease for up to 1 hour.
  • Device: Emergency Ventilator Splitter
    Device to enable oxygen delivery to two patients independently from a single ventilator.

Recruiting Locations

More Details

NCT ID
NCT04381013
Status
Withdrawn
Sponsor
Stanford University