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).
Device: Life2000® 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.
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.
Exclusion Criteria:
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.
Park Nicolette
Bloomington, Minnesota, United States
Investigator: Jonathan Shelver, MD
Marissa Peterson
651 254-5321
Marissa.K.Peterson@HealthPartners.Com
Malia Remackel
Malia.Remackel@hillrom.com
Jonathan Shelver, MD, Principal Investigator
Park Nicolette