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

NCT04369599 | Enrolling By Invitation FDA Device

• 2 other identifiers: STUDY000004022025P009256
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Arterial Oxygenation Levels

  Improvement in oxygenation will be assessed by a demonstrated \>20% increase in arterial oxygen levels after 180 minutes of treatment with the V/Q Vest, with two different levels of pressure. Normal levels of arterial oxygen range from 75 to 100 millimeters of mercury (mm Hg). Low oxygenation levels necessitate supplemental oxygen.

  Baseline, Hour 1, Hour 2, Hour 3, Hour 4, 1 Hour Post-intervention

Study Arms (1)

V/Q System

EXPERIMENTAL

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

Device: V/Q System

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.

V/Q System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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%

Sponsors & Collaborators

• Emory University: lead
• Georgia Tech Research Foundation: collaborator
• Georgia Clinical & Translational Science Alliance: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Maxwell Weinmann, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 30, 2020
• Study Start: August 11, 2020
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Sharing of data will begin 9 months and end 36 months following article publication.
• Access Criteria: Data will be made available for sharing with researchers who provide a methodologically sound proposal, in order to achieve aims stated in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (link to be provided).

Locations

US (1)