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Could a simple vest help COVID-19 patients breathe easier?

NCT ID NCT04369599

Disease control Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests a non-invasive pneumatic vest designed to apply pressure to the chest wall in patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 who are on mechanical ventilators. The goal is to see if the vest can improve oxygen levels in the blood. Up to 15 participants will wear the vest for up to four hours while their oxygen response is measured.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pneumatic chest vest (V/Q System)
What this could lead to
If effective, this non-invasive device could offer a new way to improve oxygenation in critically ill patients with ARDS, potentially reducing reliance on more invasive treatments.
What could go wrong
This is a small pilot study with only 15 participants, so results may not apply broadly. The device may not improve oxygen levels as hoped, and there is a risk of discomfort or skin injury from the vest pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2020

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * Ability of a Legally Authorized Representative (LAR) to provide consent on behalf of the patient. Exclusion Criteria: * 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 * Patients with pre-existing pulmonary hypertension and pulmonary fibrosis * Bony chest trauma within the last 10 days * Contraindications to esophageal manometry including recent esophageal trauma or surgery * Abdominal compartment syndrome * Active or recent gross hemoptysis * Elevated intracranial pressure \>20 mmHg * LAR refusal to participate * Severe Scoliosis * Morbidly obese (BMI \>37) * Pregnant women * Unable to maintain oxygen saturation \> 88%

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute respiratory distress syndrome COVID -19

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.