Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients

Hill-Rom

Status: Unknown

Conditions: Covid19; Acute Respiratory Failure

Treatments: Device: Life2000® Ventilator

Study type: Interventional

Funder types: Industry

Identifiers

NCT04581161

CR-RR-2020-004

Details and patient eligibility

About

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).

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Life2000® Ventilator

Experimental group

Description:

Subjects in the active treatment group will receive ventilatory support with Life2000® Ventilator following the labeled instructions for the device.

Treatment:

Device: Life2000® Ventilator

Control Group

No Intervention group

Description:

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.