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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, hour 1, hour 2, hour 3, hour 4, 1 hour post-intervention
Awards & highlights
Study Summary
This trial is looking at whether a vest that inflates and deflates around the chest can help improve oxygenation for people with ARDS who have COVID-19 and are on mechanical ventilation.
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%.Check my eligibility
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.See study design
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 βYesβ for the criteria belowSelect...
I am on a ventilator due to severe lung issues with specific oxygen levels.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Arterial Oxygenation Levels
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.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,537 Total Patients Enrolled
Georgia Tech Research FoundationUNKNOWN
Georgia Clinical & Translational Science AllianceUNKNOWN
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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