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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 β€œYes” for the criteria below
Select...
I am on a ventilator due to severe lung issues with specific oxygen levels.

Timeline

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

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.

Find a Location

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

V/Q System (Pneumatic Device) Clinical Trial Eligibility Overview. Trial Name: NCT04369599 β€” N/A
Acute Respiratory Distress Syndrome Research Study Groups: V/Q System
Acute Respiratory Distress Syndrome Clinical Trial 2023: V/Q System Highlights & Side Effects. Trial Name: NCT04369599 β€” N/A
V/Q System (Pneumatic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04369599 β€” N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~0 spots leftby May 2024