Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients
NCT ID: NCT04581161
Last Updated: 2020-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2020-08-28
2020-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
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.
TREATMENT
NONE
Study Groups
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Life2000® Ventilator
Subjects in the active treatment group will receive ventilatory support with Life2000® Ventilator following the labeled instructions for the 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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Hill-Rom
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Shelver, MD
Role: PRINCIPAL_INVESTIGATOR
Park Nicolette
Locations
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Park Nicolette
Bloomington, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Jonathan Shelver, MD
Role: primary
Other Identifiers
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CR-RR-2020-004
Identifier Type: -
Identifier Source: org_study_id
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