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

NCT04369599 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-06-15

No results posted yet for this study

Summary

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.

Conditions

  • Acute Respiratory Distress Syndrome
  • COVID-19

Interventions

DEVICE

V/Q System

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.

Sponsors & Collaborators

  • Georgia Tech Research Foundation

    collaborator UNKNOWN

  • Georgia Clinical & Translational Science Alliance

    collaborator UNKNOWN

  • Emory University

    lead OTHER

Principal Investigators

  • Maxwell Weinmann, MD · Emory University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04369599 on ClinicalTrials.gov