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

Not Applicable

Withdrawn

• Conditions: COVID-19
• Interventions: Device: Emergency Ventilator Splitter

• Registration Number: NCT04381013
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-08
• Status Verified: 2021-06
• Study Start: 2021-06
• Last Update Submitted: 2021-06-22
• Last Update Posted: 2021-06-25
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 2: ECHO treatment	Emergency Ventilator Splitter	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 1: Routine surgery	Emergency Ventilator Splitter	As part of routine cardio-thoracic surgery, endotracheal tubes split from ventilator delivering oxygen independently to each lung for up to 1 minute.
Phase 3: COVID-19 treatment	Emergency Ventilator Splitter	Endotracheal tubes split from ventilator delivering oxygen independently to two patients with COVID-19 disease for up to 1 hour.

Primary Outcome Measures

Name	Time	Method
Completion of 24-hour test	Up to 1 hour	This outcome will measure whether the device will function for respiratory support for 1 hour (yes or no; phase 3 only)
Completion of 1-minute test	Up to 1 minute	This outcome will measure whether the device will function for respiratory support for 1 minute (yes or no; phase 1 only)

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States