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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

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Withdrawn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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.