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

June 22, 2021 updated by: Stanford University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of 1-minute test
Time Frame: 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)
Up to 1 minute
Completion of 24-hour test
Time Frame: Up to 1 minute
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
Time Frame: 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)
Up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Joseph Woo, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Actual)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 57573

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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