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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Life2000® Ventilator | Experimental | Subjects 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Life2000® Ventilator | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PEEP level | What level of PEEP is required to ensure adequate ventilation in COVID-19 patients with mild to moderate ARF/ARDS. | 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. |
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Inclusion Criteria:
Patients who meet all of the following inclusion criteria and no exclusion criteria will be included in the study:
Exclusion Criteria:
Patients who meet one or more of the following exclusion criteria will not be eligible for the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marissa Peterson | Contact | 651 254-5321 | Marissa.K.Peterson@HealthPartners.Com | |
| Malia Remackel | Contact | Malia.Remackel@hillrom.com |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Shelver, MD | Park Nicolette | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Park Nicolette | Recruiting | Bloomington | Minnesota | 55425 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
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|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |