Trans Thoracic Manipulation of Ventilation/Perfusion: the V/Q System

Enrolling by invitation · Not applicable

Conditions studied: Acute Respiratory Distress Syndrome, COVID-19

In brief

The purpose of this pilot study is to measure the impact of non-invasive pneumatic manipulation of transthoracic pressure on oxygenation in patients with Acute Respiratory Distress Syndrome (ARDS) due to Coronavirus Disease 2019 (COVID 19) who are on mechanical ventilator support. This will be achieved by a pneumatic Vest placed around the chest wall of consenting patients who meet inclusion criteria. The Vest is essentially a non-invasive segmental device placed upon the anterior and posterior right and left aspects of the chest wall. The researchers have the ability to inflate and deflate the chambers of the Vest to achieve preset pressures as determined by the protocol and observe the patient's physiological response. Participants will have up to four hours of intervention with the study intervention, followed by 1 hour of post-intervention observation.

Key facts

Study ID

NCT04369599

Run by

Emory University

People needed

15

Starts

2020-08-11

Expected to finish

2026-11-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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%

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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