Recruiting

Life2000® Ventilator

Sponsor:

Hill-Rom

Code:

NCT04581161

Conditions

Acute Respiratory Failure

Covid19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Life2000® Ventilator

Study Details

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).

Conditions

Acute Respiratory Failure

Covid19

Study ID

NCT04581161

Start date

Aug 28, 2020

Status verified date

Oct, 2020

Completion date

Oct, 2020

Anticipated

Primary completion date

Oct, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Life2000® Ventilator

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

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.

Interventions

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Marissa Peterson

651 254-5321Marissa.K.Peterson@HealthPartners.Com

Malia Remackel

Malia.Remackel@hillrom.com

Locations

Park Nicolette

Recruiting

Bloomington, Minnesota, United States, 55425

More Information

Sponsor

Hill-Rom

Last update posted

Oct 9, 2020

Last verified

Oct, 2020

Keywords

  • ARDS
  • PEEP
  • Respiratory Rate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hill-Rom on 2020-10-09.