What side effects are associated with this type of intervention?

Common treatments for ARDS, such as mechanical ventilation, prone positioning, and high PEEP, can have several side effects. Mechanical ventilation may lead to ventilator-induced lung injury, barotrauma, and infections. Prone positioning can cause pressure sores and facial edema. High PEEP can result in decreased cardiac output and barotrauma. Non-invasive pneumatic manipulation of transthoracic pressure, like the pneumatic vest, is less studied, but potential side effects could include discomfort, skin irritation, and potential interference with other medical devices.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for ARDS that are similar to the non-invasive pneumatic manipulation of transthoracic pressure, such as the pneumatic vest being studied. Current ARDS treatments primarily involve supportive care, including mechanical ventilation strategies like low tidal volume ventilation and prone positioning. Pharmacological agents and other mechanical interventions, such as inhaled nitric oxide and liquid ventilation, have not shown consistent benefits in clinical trials and are not routinely recommended.

What other types of research exist?

Promising, novel alternatives to the Pneumatic Vest for ARDS patients include extracorporeal membrane oxygenation (ECMO), prone positioning, and inhaled nitric oxide. These interventions have shown efficacy in multiple trials and are considered advanced supportive measures for severe ARDS. Additionally, high-frequency chest wall oscillation and positive expiratory pressure physiotherapy, while primarily used in cystic fibrosis, may offer potential benefits for ARDS patients.

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Pneumatic Device

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

N/A

Waitlist Available

Led By Maxwell Weinmann, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presentation with acute respiratory distress syndrome (ARDS) requiring intubation with mechanical ventilator support. ARDS will be defined by the ratio of the partial pressure of oxygen in the patient's arterial blood (PaO2) to the fraction of oxygen in the inspired air (FiO2) as being < 300.

Be older than 18 years old

Must not have

Morbidly obese (BMI >37)

Presence of cutaneous wounds that would be compromised by the Vest including stage 3 or greater pressure ulcers and the presence of actively treated burns

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, hour 1, hour 2, hour 3, hour 4, 1 hour post-intervention

Awards & highlights

No Placebo-Only Group

Summary

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 the study for?

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%.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort due to the pressure changes from the vest application. There could also be risks related to worsening of existing injuries or conditions such as hemoptysis (coughing up blood), increased intracranial pressure or aggravating any present cutaneous wounds.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is over 37.

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

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I have been diagnosed with abdominal compartment syndrome.

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I have severe scoliosis.

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I have recently coughed up a significant amount of blood.

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I have high blood pressure in my lungs or lung scarring.

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I have not had recent esophageal surgery or trauma.

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My oxygen levels often fall below 88%.

Select...

I have chosen not to participate in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, hour 1, hour 2, hour 3, hour 4, 1 hour post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, hour 1, hour 2, hour 3, hour 4, 1 hour post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, hour 1, hour 2, hour 3, hour 4, 1 hour post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Arterial Oxygenation Levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: V/Q SystemExperimental Treatment1 Intervention

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Acute Respiratory Distress Syndrome (ARDS) focus on improving oxygenation and minimizing lung injury. Mechanical ventilation strategies, such as low tidal volume ventilation (LTVV), aim to reduce ventilator-induced lung injury by using smaller breaths. Prone ventilation improves oxygenation by redistributing lung perfusion and ventilation. Conservative fluid management reduces pulmonary edema, thereby improving lung function. Pharmacotherapy, including glucocorticoids, can reduce inflammation in the lungs. The non-invasive pneumatic manipulation of transthoracic pressure, as studied with the Pneumatic Vest, aims to enhance oxygenation by externally adjusting chest wall pressures, potentially improving ventilation-perfusion matching without the need for invasive procedures. These treatments are crucial for ARDS patients as they address the underlying issues of hypoxemia and lung injury, which are central to the disease's high morbidity and mortality.

Adult respiratory distress syndrome: diagnosis and management.Emerging drugs for treating the acute respiratory distress syndrome.Pathophysiology and implications for treatment of acute respiratory distress syndrome.