Status:
ENROLLING_BY_INVITATION
Trans Thoracic Manipulation of Ventilation/Perfusion: the V/Q System
Lead Sponsor:
Emory University
Collaborating Sponsors:
Georgia Tech Research Foundation
Georgia Clinical & Translational Science Alliance
Conditions:
Acute Respiratory Distress Syndrome
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Since the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) surfaced at the end of 2019, transmission has been rapid and particularly lethal. Death is most commonly due to ARDS which has be...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04369599
Start Date
August 11 2020
End Date
May 1 2026
Last Update
June 15 2025
Active Locations (1)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322