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

NCT04581161 | Unknown FDA Device

• 1 other identifier: CR-RR-2020-004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Respiratory Failure; Covid19

Keywords

ARDS; PEEP; Respiratory Rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PEEP level

  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.

Study Arms (2)

Life2000® Ventilator

EXPERIMENTAL

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

Device: Life2000® Ventilator

Control Group

NO INTERVENTION

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.

Interventions

Life2000® Ventilator 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.

Life2000® Ventilator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hill-Rom: lead

Study Sites (1)

Park Nicolette

Bloomington, Minnesota, 55425, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jonathan Shelver, MD

  Park Nicolette

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marissa Peterson

CONTACT

651 254-5321; Marissa.K.Peterson@HealthPartners.Com

Malia Remackel

CONTACT

Malia.Remackel@hillrom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: October 9, 2020
• Study Start: August 28, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)