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

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ClinicalTrials.gov Identifier: NCT04369599
Recruitment Status : Enrolling by invitation
First Posted : April 30, 2020
Last Update Posted : April 12, 2021
Sponsor:
Collaborators:
Georgia Tech Research Foundation
Georgia Clinical & Translational Science Alliance
Information provided by (Responsible Party):
Maxwell Weinmann, Emory University

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome COVID-19 Device: V/Q System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trans Thoracic Manipulation of Ventilation/Perfusion: the V/Q System
Actual Study Start Date : August 11, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369599


Locations
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United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Georgia Tech Research Foundation
Georgia Clinical & Translational Science Alliance
Investigators
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Principal Investigator: Maxwell Weinmann, MD Emory University
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Responsible Party: Maxwell Weinmann, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT04369599    
Other Study ID Numbers: STUDY00000402
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial will be made available for sharing, after deidentification.
Supporting Materials: 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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury