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

NCT ID: NCT04381013

Last Updated: 2021-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2021-07-31

Brief Summary

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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

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Conditions

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COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Emergency Ventilator Splitter

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Emergency Ventilator Splitter

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Emergency Ventilator Splitter

Intervention Type DEVICE

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

Interventions

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Emergency Ventilator Splitter

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Woo, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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57573

Identifier Type: -

Identifier Source: org_study_id

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