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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with severe breathing problems caused by COVID-19, known as Acute Respiratory Distress Syndrome (ARDS). The treatment, called the V/Q System, uses a special Vest that gently squeezes the chest to improve oxygen levels. The researchers aim to determine if this Vest can help ventilated patients breathe better. The trial seeks patients on ventilators due to ARDS from COVID-19, with consent provided by a legally authorized representative. As an unphased trial, it offers patients the chance to contribute to important research that could enhance future ARDS treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for patients with ARDS due to COVID-19?

Research has shown that the V/Q System, a special vest designed to assist COVID-19 patients with lung issues, is undergoing testing for safety and efficacy. This vest inflates and deflates to help improve oxygen levels. Although direct safety data from studies specifically on this vest is not available, some information can be gathered from its use in clinical trials.

The trial is in a "Not Applicable" phase, indicating limited human safety data may be available. However, testing in a clinical setting suggests it has met basic safety standards. The V/Q System is non-invasive, meaning it doesn't require surgery or entering the body, which typically reduces the risk of serious side effects.

While this doesn't guarantee complete safety, it suggests the treatment is considered safe enough for testing on individuals with severe lung issues. Researchers will closely monitor participants during and after using the vest to ensure their well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for acute respiratory distress syndrome (ARDS) in COVID-19, which often involve mechanical ventilation and supportive care, the V/Q System offers a novel approach. Researchers are excited because this system targets ventilation-perfusion (V/Q) mismatch, a key problem in ARDS, by optimizing the delivery of oxygen and carbon dioxide exchange directly in the lungs. This new method could improve breathing efficiency and reduce the need for invasive procedures, offering a more targeted and potentially less harmful solution for patients.

What evidence suggests that this V/Q System is effective for ARDS in COVID-19?

Research has shown that improving the match between air and blood flow in the lungs can reduce deaths in the ICU for patients with moderate to severe ARDS, a serious lung condition. In this trial, participants will receive therapy with the V/Q System, which uses an air pressure-based Vest around the chest to enhance breathing. This method resembles turning patients onto their stomachs, a technique shown to quickly boost oxygen levels in ARDS patients. By improving oxygen levels, the V/Q System might lower complications and increase survival rates in ARDS caused by COVID-19. Early results from similar methods suggest they could help manage severe breathing problems. ^{1 6 7 8 9}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11958859/

Time-dependent effects of prone position on ventilation ... Conclusions. In COVID-19-induced ARDS patients, prone positioning initially improves oxygenation and V/Q matching by enhancing ventilation ...

2. annalsofintensivecare.springeropen.com annalsofintensivecare.springeropen.com/articles/10.1186/s13613-025-01489-1

Association between ventilation–perfusion matching ... Improvement in V/Q matching 4 h within the first PP is associated with lower ICU mortality in patients with moderate to severe ARDS.

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2765302

Management of COVID-19 Respiratory Distress Soon after onset of respiratory distress from COVID, patients initially retain relatively good compliance despite very poor oxygenation. Minute ventilation is ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8108193/

Outcomes of acute respiratory distress syndrome in COVID ... The overall all-cause mortality rate for the COVID-19 group was 30.9% (95% CI = 21.3%; 42.6%) while the overall mortality rate for the ARDS group was 26.1% (95% ...

5. jphe.amegroups.org jphe.amegroups.org/article/view/7774/html

Pronation in acute respiratory distress syndrome (ARDS ... Prone position has been used since the 1970s to treat severe hypoxemia in patients with ARDS because of its effectiveness at improving gas exchange. Compared ...

6. withpower.com withpower.com/trial/phase-respiratory-distress-syndrome-newborn-7-2020-6e1f2

V/Q System for Acute Respiratory Distress Syndrome in ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11012401/

The Respiratory Mechanics of COVID-19 ... - PubMed Central They found that the COVID-19 ARDS patients had better compliance and larger end-expiratory gas volumes than their non-COVID counterparts matched ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2667100X22000159

Assessment of respiratory support decision and the ... To 28 days after ICU admission, 18 (39.1%) patients died. Survivors had a significantly higher respiratory support decision score than non-survivors (15.0 [10.3 ...

9. nature.com nature.com/articles/s41392-025-02127-9

Advances in acute respiratory distress syndrome However, there is no significant difference in overall hospital mortality between men (40.2%) and women (40.2%), although women have been ...