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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04581161
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Hill-Rom

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).

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Covid19 Device: Life2000® Ventilator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients
Actual Study Start Date : August 28, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020


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.



Primary Outcome Measures :
  1. Life2000® Compared to HFNC (AIRVO) [ 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. ]
    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 :
  1. PEEP level [ 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. ]
    What level of PEEP is required to ensure adequate ventilation in COVID-19 patients with mild to moderate ARF/ARDS.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581161


Contacts
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Contact: Marissa Peterson 651 254-5321 Marissa.K.Peterson@HealthPartners.Com
Contact: Malia Remackel Malia.Remackel@hillrom.com

Locations
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United States, Minnesota
Park Nicolette Recruiting
Bloomington, Minnesota, United States, 55425
Contact: Jonathan Shelver, MD         
Sponsors and Collaborators
Hill-Rom
Investigators
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Principal Investigator: Jonathan Shelver, MD Park Nicolette
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Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT04581161    
Other Study ID Numbers: CR-RR-2020-004
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Hill-Rom:
ARDS
PEEP
Respiratory Rate
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases