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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04581161
• Other study ID #: CR-RR-2020-004
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: October 2020

Study information

• Verified date: October 2020
• Source: Hill-Rom
• Contact: Marissa Peterson
• Phone: 651 254-5321
• Email: Marissa.K.Peterson[@]HealthPartners.Com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Covid19
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Park Nicolette	Bloomington	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Hill-Rom

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PEEP level	What level of PEEP is required to ensure adequate ventilation in COVID-19 patients with mild to moderate ARF/ARDS.	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.