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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04369599
Status
Enrolling By Invitation

Conditions

  • Acute Respiratory Distress Syndrome
  • COVID-19

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • V/Q System — DEVICE
    With the patient supine, sedated, and hemodynamically stable, the Vest is placed upon the patient and secured by clinicians and staff. All chambers of the Vest will be inflated simultaneously. First inflation will be for one hour to a pressure of 0.4 psi. Subsequent inflations at 0.8 and finally 1.2 psi will be performed for one hour each. Participants will be treated for up to four hours and then will be observed for an additional hour.

Study Details

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 Dates

Start date
Aug 11, 2020
Status verified
May 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: V/Q System
    Participants with acute respiratory failure will undergo therapy with the V/Q System.

Primary Outcome Measure

Change in Arterial Oxygenation Levels [ Time Frame: Baseline, Hour 1, Hour 2, Hour 3, Hour 4, 1 Hour Post-intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322-

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