COVID-19NCT04381013
Emergency Ventilator Splitting Between Two or More Patients (COVID-19)
A study testing Emergency Ventilator Splitter in people with COVID-19, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Emergency Ventilator Splitter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2021to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Phase I
- Significant cardiac comorbidities
- Liver disease
- Phase II
- Significant cardiac comorbidities
- Pre or Post-transplant patient
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID-19
- Being tested
- Emergency Ventilator Splitter
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Ventilator SplitterDevice
Device to enable oxygen delivery to two patients independently from a single ventilator.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Emergency Ventilator Splitter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study startJun 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: Different approach to be taken for the device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Woo, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381013
- Sponsor's protocol ID
- 57573
- Status last verified
- Jun 2021
- First submitted
- 7 May 2020
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Ventilator Splitting Between Two or More Patients Using a Single Ventilator to Address Critical Ventilator Shortages During a Pandemic
- ClinicalTrials.gov ID
- NCT04381013
- Acronym / sponsor ID
- 57573
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Different approach to be taken for the device.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Routine surgery | Experimental | Device: Emergency Ventilator SplitterAs part of routine cardio-thoracic surgery, endotracheal tubes split from ventilator delivering oxygen independently to each lung for up to 1 minute. |
| Phase 2: ECHO treatment | Experimental | Device: Emergency Ventilator SplitterDuring 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. |
| Phase 3: COVID-19 treatment | Experimental | Device: Emergency Ventilator SplitterEndotracheal tubes split from ventilator delivering oxygen independently to two patients with COVID-19 disease for up to 1 hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Phase I
- Phase II
- Phase III
Key exclusion criteria (10 listed)
- Phase I
- Phase II
- Phase III
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency Ventilator SplitterDevice to enable oxygen delivery to two patients independently from a single ventilator. | Device | Phase 1: Routine surgery, Phase 2: ECHO treatment, Phase 3: COVID-19 treatment |
Primary outcome
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)
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)
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Individual participant dataSharing planned: No. No plan to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Woo, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Ventilator Splitter in people with COVID-19, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of 1-minute test (time frame: Up to 1 minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.