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

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Maxwell Weinmann, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+