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
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome COVID-19||Device: V/Q System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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|