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

Not Applicable

• Conditions: Acute Respiratory Failure; Covid19
• Interventions: Device: Life2000® Ventilator

• Registration Number: NCT04581161
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-19
• Study Start: 2020-08-28
• Status Verified: 2020-10
• Primary Completion: 2020-10
• Study Completion: 2020-10
• Study First Submitted QC: 2020-10-06
• Last Update Submitted: 2020-10-06
• Study First Posted: 2020-10-09
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Life2000® Compared to HFNC (AIRVO)	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

Name	Time	Method
PEEP level	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.

Trial Locations

Locations (1)

Park Nicolette; 🇺🇸 Bloomington, Minnesota, United States