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

Stanford University

Status: Withdrawn

Conditions: COVID-19

Treatments: Device: Emergency Ventilator Splitter

Study type: Interventional

Funder types: Other

Identifiers

NCT04381013

57573

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Phase 1: Routine surgery

Experimental group

Description:

As part of routine cardio-thoracic surgery, endotracheal tubes split from ventilator delivering oxygen independently to each lung for up to 1 minute.

Treatment:

Device: Emergency Ventilator Splitter

Phase 2: ECHO treatment

Experimental group

Description:

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.

Treatment:

Device: Emergency Ventilator Splitter

Phase 3: COVID-19 treatment

Experimental group

Description:

Endotracheal tubes split from ventilator delivering oxygen independently to two patients with COVID-19 disease for up to 1 hour.

Treatment:

Device: Emergency Ventilator Splitter