Back to results

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

Primary Purpose

COVID-19

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Emergency Ventilator Splitter

About this trial

This is an interventional device feasibility trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Phase 1: Routine surgery

Phase 2: ECHO treatment

Phase 3: COVID-19 treatment

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

Completion of 1-minute test

This outcome will measure whether the device will function for respiratory support for 1 minute (yes or no; phase 1 only)

Completion of 24-hour test

This outcome will measure whether the device will function for respiratory support for 24 hours (yes or no; phase 2 only)

Completion of 24-hour test

This outcome will measure whether the device will function for respiratory support for 1 hour (yes or no; phase 3 only)

Secondary Outcome Measures

Full Information

NCT ID

NCT04381013

First Posted

May 7, 2020

Last Updated

June 22, 2021

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT04381013

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Different approach to be taken for the device.

Study Start Date

June 2021 (Anticipated)

Primary Completion Date

July 2021 (Anticipated)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1: Routine surgery

Arm Type

Experimental

Arm Description

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

Arm Title

Phase 2: ECHO treatment

Arm Type

Experimental

Arm 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.

Arm Title

Phase 3: COVID-19 treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Emergency Ventilator Splitter

Intervention Description

Device to enable oxygen delivery to two patients independently from a single ventilator.

Primary Outcome Measure Information:

Title

Completion of 1-minute test

Description

This outcome will measure whether the device will function for respiratory support for 1 minute (yes or no; phase 1 only)

Time Frame

Up to 1 minute

Title

Completion of 24-hour test

Description

This outcome will measure whether the device will function for respiratory support for 24 hours (yes or no; phase 2 only)

Time Frame

Up to 1 minute

Title

Completion of 24-hour test

Description

This outcome will measure whether the device will function for respiratory support for 1 hour (yes or no; phase 3 only)

Time Frame

Up to 1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Woo, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan to share data.

Learn more about this trial

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

We'll reach out to this number within 24 hrs