An interventional study of Life2000® Ventilator in Acute Respiratory Failure and Covid19, sponsored by Hill-Rom. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-09.
Sponsored by Hill-Rom · Not applicable, Interventional, and Treatment
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).
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 10 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Hill-Rom is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who meet all of the following inclusion criteria and no exclusion criteria will be included in the study:
Exclusion Criteria:
Patients who meet one or more of the following exclusion criteria will not be eligible for the study:
Subjects in the active treatment group will receive ventilatory support with Life2000® Ventilator following the labeled instructions for the device.
Device: Life2000® Ventilator
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.
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® 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: 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.
PEEP level
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.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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