Acute Respiratory Failure, Covid19
Conditions
Keywords
ARDS, PEEP, Respiratory Rate
Brief 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 patients from progressing to more aggressive forms of invasive mechanical ventilation (IMV).
Interventions
DEVICELife2000® Ventilator
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.
Sponsors
Hill-Rom
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Life2000® Compared to HFNC (AIRVO) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PEEP level | 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. | What level of PEEP is required to ensure adequate ventilation in COVID-19 patients with mild to moderate ARF/ARDS. |
Countries
United States
Contacts
Primary ContactMarissa Peterson
Backup ContactMalia Remackel
Outcome results
None listed