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

Primary Purpose

Acute Respiratory Failure, Covid19

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Life2000® Ventilator
Sponsored by
Hill-Rom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring ARDS, PEEP, Respiratory Rate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Park NicoletteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Life2000® Ventilator

Control Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 19, 2020
Last Updated
October 6, 2020
Sponsor
Hill-Rom
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1. Study Identification

Unique Protocol Identification Number
NCT04581161
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hill-Rom

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Covid19
Keywords
ARDS, PEEP, Respiratory Rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Life2000® Ventilator
Arm Type
Experimental
Arm Description
Subjects in the active treatment group will receive ventilatory support with Life2000® Ventilator following the labeled instructions for the device.
Arm Title
Control Group
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Life2000® Ventilator
Intervention Description
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 Outcome Measure Information:
Title
Life2000® Compared to HFNC (AIRVO)
Description
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
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 Measure Information:
Title
PEEP level
Description
What level of PEEP is required to ensure adequate ventilation in COVID-19 patients with mild to moderate ARF/ARDS.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marissa Peterson
Phone
651 254-5321
Email
Marissa.K.Peterson@HealthPartners.Com
First Name & Middle Initial & Last Name or Official Title & Degree
Malia Remackel
Email
Malia.Remackel@hillrom.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Shelver, MD
Organizational Affiliation
Park Nicolette
Official's Role
Principal Investigator
Facility Information:
Facility Name
Park Nicolette
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Shelver, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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