Official Title
Trans Thoracic Manipulation of Ventilation/Perfusion: the V/Q Vest
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.

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.

Enrolling by invitation
Acute Respiratory Distress Syndrome
COVID-19

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.
V/Q Vest

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Emory University Hospital
Atlanta, Georgia, 30322

Maxwell Weinmann, MD
Principal Investigator
Emory University

Emory University
Georgia Tech Research Foundation
Georgia Clinical & Translational Science Alliance
NCT Number
MeSH Terms
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury