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Trans Thoracic Manipulation of Ventilation/Perfusion: the V/Q Vest for COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369599
Recruitment Status : Enrolling by invitation
First Posted : April 30, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Georgia Tech Research Foundation
Georgia Clinical & Translational Science Alliance
Information provided by (Responsible Party):
Maxwell Weinmann, Emory University

Brief Summary:
The objective of this research is optimizing oxygenation in patients in the setting of acute hypoxic respiratory failure in relation to corona virus disease 2019 (COVID-19) through non-invasive manipulation as a complementary therapy to traditional advanced mechanical ventilator support, or as a marker of responsivity to supportive therapies. The intent is to determine if it is possible to physically improve the ability of the lungs to take up oxygen by applying external pressure to the chest. It is hypothesized that the use of the vest for this patient population will alter the blood flow through the lungs and thereby improve oxygen levels in the body. Participants will wear the ventilation/perfusion (V/Q) vest for 2 hours and study activities will last up to 4 hours.

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

Detailed Description:

In acute severe respiratory failure due to COVID-19, current recommendations by international Critical Care Societies include placing patients who are dependent on mechanical ventilator support for their survival, on their bellies. This acts to physically redistribute blood to uninjured or minimally injured lung that can still participate in taking up oxygen. Unfortunately, not all centers are equipped or trained for this maneuver which has it's own inherent risks. The investigators are proposing that the effects of proning can be safely mimicked by the V/Q vest by applying pressure through a non invasive externally fitted vest. By 4 front and rear inflatable compartments, doctors can fine tune the redirection of blood as occurs in proning. However the vest successfully avoids the need for expensive specialized equipment, training and facilities. In addition, preliminary assessment of the technique using sand bags to apply pressure, the investigators found that those patients who did not respond to this maneuver also failed to respond to more costly therapies. The vest potentially acts as a therapy in and of itself and as an indicator of what is optimal treatment for the COVID-19 patient while saving hospital resources and economic burden.

The study procedures will take less than 4 hours to complete for each subject enrolled. During this time, the subject will be sedated. The ventilation perfusion vest consists of two parts for ease of placement. The vest has multiple chambers which will be inflated to different pressures. The vest will be inflated for 1 hour at a specific pressure and the pressure will then be increased for a second hour, followed by one final hour at additional increased pressure for the purpose of the study. This will help to evaluate which pressure is optimal for altering lung function and oxygen levels.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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 Vest
Actual Study Start Date : August 11, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021


Arm Intervention/treatment
Experimental: V/Q Vest
Participants with acute respiratory failure due to COVID-19 will undergo therapy with the V/Q Vest.
Device: V/Q Vest
Application of the V/Q vest will be in 2 phases. The first phase is determination of patient responsivity and optimal anatomical positioning of the inflation chambers. The inflation sequence (i.e., anterior versus posterior chambers) of the vest will be based upon both radiologic appearance and patient response to sequential anterior and posterior inflation. This evaluation will take place over a period of between 1-2 hours. During this phase, sequential posterior and anterior chamber inflation to 1.0 psi will take place. Responsivity will be determined by impact upon oxygenation as demonstrated by arterial blood gas measurement after 1 hour of inflation of the anterior or posterior chambers. This is then followed by Phase 2 which is the determination of optimal inflation pressure of the chambers in positions demonstrated by Phase 1. Inflation will take place in 3 stages while the patient is supine and sedated. Inflation will be to 1.0, 1.5 and 2.0 psi for one hour periods.




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


Secondary Outcome Measures :
  1. Number of participants requiring advanced therapy [ Time Frame: Hour 3 ]
    The study aims to determine if the vest is a predictor of response to more advanced therapy. The number of participants requiring advanced treatment will be documented.

  2. Number of participants avoiding proning ventilation [ Time Frame: Hour 3 ]
    This study aims to determine if the vest allows avoidance in proning ventilation.

  3. Number of participants delaying proning ventilation [ Time Frame: Hour 3 ]
    This study aims to determine if the vest allows for a delay in proning ventilation.



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) in relation to COVID-19, currently intubated and on ventilator support
  • Age >18 years
  • Ability to provide informed consent

Exclusion Criteria:

  • Presence of cutaneous wounds that would be compromised by the vest
  • Presence of active burns
  • Chest surgery within the last 5 days
  • Family refusal to participate
  • Pregnant women

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: September 16, 2020
Last Verified: September 2020
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, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury