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

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

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).

Study Overview

• Status: Unknown
• Conditions: Covid19; Acute Respiratory Failure
• Intervention / Treatment: Device: Life2000® Ventilator

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Bloomington, Minnesota, United States, 55425
      • Recruiting
      • Park Nicolette
      • Contact: Jonathan Shelver, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Life2000® Ventilator; Subjects in the active treatment group will receive ventilatory support with Life2000® Ventilator following the labeled instructions for the device.	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.
No Intervention: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life2000® Compared to HFNC (AIRVO)	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PEEP level	What level of PEEP is required to ensure adequate ventilation in COVID-19 patients with mild to moderate ARF/ARDS.	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.

Collaborators and Investigators

• Sponsor: Hill-Rom
• Investigators: Principal Investigator: Jonathan Shelver, MD, Park Nicolette

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2020
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: ARDS; Respiratory Rate; PEEP
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: CR-RR-2020-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes