Acute Respiratory FailureNCT04581161
Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients
A study testing Life2000® Ventilator in people with Acute Respiratory Failure and Covid19, run by Hill-Rom at 1 site in United States.
Trial summary
To evaluate the use of Life2000® Ventilator, a novel proportional open ventilation system in critical care use of acute onset of respiratory failure (ARF) and mild to moderate forms of acute respiratory distress syndrome (ARDS) in COVID-19 patients and its ability to provide effective ventilatory benefits and or delay… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Covid19
- What is being tested?
- Life2000® Ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2020to Oct 2020
- 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
- Patients who meet all of the following inclusion criteria and no exclusion criteria will be included in the study:
- A diagnosed or suspected COVID-19 patient requiring non-invasive ventilatory support and admitted to hospital
- PaO2/FiO2 ≤ 300 (corrected for altitude)
- RR ≤ 30/min during early use of oxygen
- Adults of 18 years and older
- Provision of written informed consent to participate in study by subject or legal representative.
Who cannot join
- Patients who meet one or more of the following exclusion criteria will not be eligible for the study:
- Patients under the age of 18
- Patients who are not diagnosed or suspected of having an acute COVID-19 illness
- Patients who do not require non-invasive ventilatory interventions, PaO2/FiO2 > 300 (corrected for altitude) and tolerating supplemental oxygen with SpO2 saturations ≥ 92%.
- Patients who require immediate IMV upon admission or have a RR > 30/min on early oxygen intervention.
- Thoracoabdominal desynchrony and paradoxical breathing at admission
- Patients in immediate need of or on vasopressors upon ICU admission
- Patients or legal representatives who are unwilling or unable to provide written consent.
Trial locations and contacts
1 site in 1 country.
Malia Remackel contact
United States1 site, 1 recruiting
- Recruiting
Park Nicolette
Bloomington, Minnesota, 55425
Jonathan Shelver, MD
About this study
Official title: A Novel Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients
To evaluate the use of Life2000® Ventilator, a novel proportional open ventilation system in critical care use of acute onset of respiratory failure (ARF) and mild to moderate forms of acute respiratory distress syndrome (ARDS) in COVID-19 patients and its ability to provide effective ventilatory benefits and or delay patients from progressing to more aggressive forms of invasive mechanical ventilation (IMV).
- Conditions
- Acute Respiratory Failure, Covid19
- Being tested
- Life2000® Ventilator
- Keywords
- ARDS, PEEP, Respiratory Rate
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life2000® VentilatorDevice
POV support (Life2000) will be administered in six (6) to ten (ten) enrolled subjects based on clinical protocol flowchart (Appendix C). Specifically, if it is determined that a COVID-19 subject who would currently be considered for HFNC under current standard of treatment, will be eligible for POV treatment.
The prescribed therapy regimen, including duration of therapy will be documented and COVID-19 patients who fail therapy and require IMV will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Life2000® Ventilator | Experimental | Subjects in the active treatment group will receive ventilatory support with Life2000® Ventilator following the labeled instructions for the device. Receives: Device: Life2000® Ventilator |
| Control Group | No intervention | Subjects in the control group will be identified from the population of patients previously admitted to the study site with COVID-19 infection who required non-invasive oxygen therapy with HFNC but were not treated with NIV therapy. Subject data will be collected retrospectively from the medical record. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life2000® Compared to HFNC (AIRVO)
Compared to HFNC (AIRVO), does the Life2000® Ventilator provide clinically relevant ventilatory support to COVID-19 patients with mild to moderate ARF or ARDS to prevent IMV.
Measured: Time frame measured will include date that patient is admitted to hospital until date patient is discharged from hospital or death occurs with an anticipated 30 day time period, but shall not exceed 90 day time period.
Secondary outcomes (1)
PEEP level
What level of PEEP is required to ensure adequate ventilation in COVID-19 patients with mild to moderate ARF/ARDS.
Measured: Time frame measured will include date that patient is admitted to hospital until date patient is discharged from hospital or death occurs with an anticipated 30 day time period, but shall not exceed 90 day time period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start28 Aug 2020
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Subjects in the active treatment group will receive ventilatory support with Life2000® Ventilator following the labeled instructions for the device. POV support (Life2000) will be administered in six (6) to ten (ten) enrolled subjects based on clinical protocol flowchart (Appendix C). Specifically, if it is determined that a COVID-19 subject who would currently be considered for HFNC under current standard of treatment, will be eligible for POV treatment. The prescribed therapy regimen, including duration of therapy will be documented and COVID-19 patients who fail therapy and require IMV will be recorded.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Shelver, MD, Principal investigator, Park Nicolette
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581161
- Sponsor's protocol ID
- CR-RR-2020-004
- Status last verified
- Oct 2020
- First submitted
- 19 Aug 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04581161
- Acronym / sponsor ID
- CR-RR-2020-004
- Conditions
- Acute Respiratory Failure, Covid19
- Keywords
- ARDS, PEEP, Respiratory Rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 9 Oct 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.
To evaluate the use of Life2000® Ventilator, a novel proportional open ventilation system in critical care use of acute onset of respiratory failure (ARF) and mild to moderate forms of acute respiratory distress syndrome (ARDS) in COVID-19 patients and its ability to provide effective ventilatory benefits and or delay patients from progressing to more aggressive forms of invasive mechanical ventilation (IMV).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects in the active treatment group will receive ventilatory support with Life2000® Ventilator following the labeled instructions for the device. POV support (Life2000) will be administered in six (6) to ten (ten) enrolled subjects based on clinical protocol flowchart (Appendix C). Specifically, if it is determined that a COVID-19 subject who would currently be considered for HFNC under current standard of treatment, will be eligible for POV treatment. The prescribed therapy regimen, including duration of therapy will be documented and COVID-19 patients who fail therapy and require IMV will be recorded.
| Arm | Type | Receives |
|---|---|---|
| Life2000® Ventilator | Experimental | Device: Life2000® VentilatorSubjects in the active treatment group will receive ventilatory support with Life2000® Ventilator following the labeled instructions for the device. |
| Control Group | No intervention | –Subjects in the control group will be identified from the population of patients previously admitted to the study site with COVID-19 infection who required non-invasive oxygen therapy with HFNC but were not treated with NIV therapy. Subject data will be collected retrospectively from the medical record. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who meet all of the following inclusion criteria and no exclusion criteria will be included in the study:
- A diagnosed or suspected COVID-19 patient requiring non-invasive ventilatory support and admitted to hospital
- PaO2/FiO2 ≤ 300 (corrected for altitude)
- RR ≤ 30/min during early use of oxygen
- Adults of 18 years and older
Key exclusion criteria (8 listed)
- Patients who meet one or more of the following exclusion criteria will not be eligible for the study:
- Patients under the age of 18
- Patients who are not diagnosed or suspected of having an acute COVID-19 illness
- Patients who do not require non-invasive ventilatory interventions, PaO2/FiO2 > 300 (corrected for altitude) and tolerating supplemental oxygen with SpO2 saturations ≥ 92%.
- Patients who require immediate IMV upon admission or have a RR > 30/min on early oxygen intervention.
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 |
|---|---|---|
| Life2000® VentilatorPOV support (Life2000) will be administered in six (6) to ten (ten) enrolled subjects based on clinical protocol flowchart (Appendix C). Specifically, if it is determined that a COVID-19 subject who would currently be considered for HFNC under current standard of treatment, will be eligible for POV treatment. The prescribed therapy regimen, including duration of therapy will be documented and COVID-19 patients who fail therapy and require IMV will be recorded. | Device | Life2000® Ventilator |
Primary outcome
Life2000® Compared to HFNC (AIRVO)
Time frame: Time frame measured will include date that patient is admitted to hospital until date patient is discharged from hospital or death occurs with an anticipated 30 day time period, but shall not exceed 90 day time period.
Compared to HFNC (AIRVO), does the Life2000® Ventilator provide clinically relevant ventilatory support to COVID-19 patients with mild to moderate ARF or ARDS to prevent IMV.
1 secondary outcome
PEEP level
Time frame: Time frame measured will include date that patient is admitted to hospital until date patient is discharged from hospital or death occurs with an anticipated 30 day time period, but shall not exceed 90 day time period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Malia Remackel contact
Jonathan Shelver, MD principal investigator
Park Nicolette
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life2000® Ventilator in people with Acute Respiratory Failure and Covid19, run by Hill-Rom 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marissa Peterson (651 254-5321, Marissa.K.Peterson@HealthPartners.Com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life2000® Compared to HFNC (AIRVO) (time frame: Time frame measured will include date that patient is admitted to hospital until date patient is discharged from hospital or death occurs with an anticipated 30 day time period, but shall not exceed 90 day time period.). 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 9 Oct 2020.