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

NCT04381013 | Withdrawn FDA Device

• 1 other identifier: 57573
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• 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)

  Up to 1 minute

• 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)

  Up to 1 minute

• 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)

  Up to 1 hour

Study Arms (3)

Phase 1: Routine surgery

EXPERIMENTAL

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

Phase 2: ECHO treatment

EXPERIMENTAL

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

Phase 3: COVID-19 treatment

EXPERIMENTAL

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

Device: Emergency Ventilator Splitter

Interventions

Emergency Ventilator Splitter DEVICE

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

Phase 1: Routine surgery; Phase 2: ECHO treatment; Phase 3: COVID-19 treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Joseph Woo, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 8, 2020
• Study Start: June 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)