Trans Thoracic Manipulation of Ventilation/Perfusion: the V/Q Vest for COVID-19
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|ClinicalTrials.gov Identifier: NCT04369599|
Recruitment Status : Enrolling by invitation
First Posted : April 30, 2020
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome COVID-19||Device: V/Q Vest||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- Number of participants avoiding proning ventilation [ Time Frame: Hour 3 ]This study aims to determine if the vest allows avoidance in proning ventilation.
- 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.
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
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Maxwell Weinmann, MD||Emory University|