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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04381013
• Other study ID #: 57573
• Status: Withdrawn
• Phase: N/A
• Start date: June 2021
• Est. completion date: July 2021

Study information

• Verified date: June 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Emergencies

Intervention

Device:
• Emergency Ventilator Splitter
Device to enable oxygen delivery to two patients independently from a single ventilator.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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