V/Q System for Acute Respiratory Distress Syndrome in COVID-19

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Pulmonary hypertension, Pulmonary fibrosis, Morbid obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 hours

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a special Vest that helps COVID-19 patients with severe lung issues breathe better. The Vest inflates and deflates to improve oxygen levels in the blood. It aims to provide a safer and simpler alternative to turning patients onto their stomachs.

Research Team

Maxwell Weinmann, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for patients with severe breathing problems due to ARDS from COVID-19, who are on ventilators. They must have a specific oxygenation measurement (PaO2/FiO2 < 300) and consent from a legal representative. It's not for those with recent chest trauma, high brain pressure, certain esophageal conditions, pre-existing lung issues like pulmonary hypertension or fibrosis, skin wounds affected by the Vest device, severe scoliosis, extreme obesity (BMI >37), pregnant women or if they can't maintain an oxygen saturation above 88%.

Inclusion Criteria

I am on a ventilator due to severe lung issues with specific oxygen levels.

My legal representative can consent for me.

Exclusion Criteria

My BMI is over 37.

I have severe skin wounds or burns that could worsen with pressure.

I have been diagnosed with abdominal compartment syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo therapy with the V/Q System for up to 4 hours

4 hours

1 visit (in-person)

Post-intervention Observation

Participants are observed for 1 hour following the intervention to monitor changes in arterial oxygenation levels

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• V/Q System

Trial Overview The study tests a non-invasive V/Q System Vest that manipulates chest pressure to improve oxygen levels in ARDS patients caused by COVID-19. The vest inflates and deflates around the patient's chest to change pressures while monitoring their response during and after a four-hour intervention period.

Participant Groups

Group I: V/Q System Experimental Treatment 1 Intervention

Participants with acute respiratory failure will undergo therapy with the V/Q System.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Georgia Tech Research Foundation

Collaborator

Trials

1

Recruited

20+

Georgia Clinical & Translational Science Alliance

Collaborator

Trials

1

Recruited

20+