Clinical trial NCT04581161: Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients
Official title: A Novel Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Failure
Covid19
Keywords: ARDS
PEEP
Respiratory Rate
Lead sponsor: Hill-Rom
Sponsor class: INDUSTRY
First posted: 2020-10-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Life2000® Compared to HFNC (AIRVO)
timeFrame: 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:
measure: PEEP level
timeFrame: 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.
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Park Nicolette
state: Minnesota
Study officials:
affiliation: Park Nicolette
name: Jonathan Shelver, MD
role: PRINCIPAL_INVESTIGATOR
References: