Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients
Status unconfirmed · Not applicable
Conditions studied: Acute Respiratory Failure, Covid19
In brief
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).
Key facts
- Study ID
- NCT04581161
- Run by
- Hill-Rom
- People needed
- 10
- Starts
- 2020-08-28
- Expected to finish
- 2020-10-01
- Last updated by the study team
- 2020-10-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Park Nicolette — Bloomington, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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