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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 belowSelect...
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:Select...
My BMI is over 37.
Select...
I have severe skin wounds or burns that could worsen with pressure.
Select...
I have been diagnosed with abdominal compartment syndrome.
Select...
I have severe scoliosis.
Select...
I have recently coughed up a significant amount of blood.
Select...
I have high blood pressure in my lungs or lung scarring.
Select...
I have not had recent esophageal surgery or trauma.
Select...
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
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.
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.
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.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,701 Previous Clinical Trials
2,604,695 Total Patients Enrolled
Georgia Tech Research FoundationUNKNOWN
Georgia Clinical & Translational Science AllianceUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on a ventilator due to severe lung issues with specific oxygen levels.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.I have severe scoliosis.I have recently coughed up a significant amount of blood.I have high blood pressure in my lungs or lung scarring.I have not had recent esophageal surgery or trauma.My legal representative can consent for me.My oxygen levels often fall below 88%.You have had a chest injury to your bones within the last 10 days.I have chosen not to participate in this study.You have high pressure inside your head.
Research Study Groups:
This trial has the following groups:- Group 1: V/Q System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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