Actively Recruiting
Measuring the Impact of Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury in Mechanically Ventilated Patients
Led by Peninsula Health · Updated on 2024-03-20
15
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Peninsula Health
Lead Sponsor
M
Monash University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a device called PrismaLung for extracorporeal carbon dioxide removal (ECCO2R) in adults with acute respiratory distress syndrome (ARDS) who are mechanically ventilated. The study focuses on how this device may help reduce ventilator-induced lung injury by lowering harmful pressures and inflammation in the lungs. This observational study is sponsored by Peninsula Health and aims to better understand how managing carbon dioxide levels can impact lung injury and patient outcomes. Participants will receive low flow extracorporeal carbon dioxide removal using the PrismaLung device while receiving lung protective ventilation. The study measures include monitoring airway pressures at 72 and 144 hours after starting ECCO2R. Researchers also assess lung inflammation by measuring interleukin levels in bronchoalveolar lavage fluid and blood to evaluate the impact of treatment on lung injury. During the study, adult patients diagnosed with ARDS will be closely monitored with clinical assessments, laboratory tests, and pressure measurements. The main outcome is the reduction in driving airway pressure, while secondary outcomes include decreased pulmonary inflammation. The study excludes patients with ARDS lasting more than 72 hours or other severe conditions. Participation involves continuous monitoring over several days to understand the effects of the PrismaLung device on lung injury and respiratory function.
CONDITIONS
Brief Title
Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (18 years or older) with diagnosis of ARDS as per Berlin Definition
- Driving pressure (ΔP) greater than 14 and/or Plateau pressure greater than or equal to 25 cm H2O
- Respiratory rate greater than 20 breaths per minute
- Blood pH less than 7.25 and PaCO2 greater than 45 mmHg
You will not qualify if you...
- ARDS lasting more than 72 hours at time of inclusion
- High pressure ventilation (Plateau pressure greater than 30 cm H2O) or high FiO2 (greater than 0.8) ventilation for more than 168 hours (7 days)
- Life threatening hemodynamic instability with ongoing arrhythmias unresponsive to treatment
- Contraindication to limited anticoagulation
- Treatment limitations including not for resuscitation and not for reintubation
- Patients with potentially irreversible respiratory failure caused by conditions such as pulmonary fibrosis
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive extracorporeal carbon dioxide removal using PrismaLung+ to help reduce ventilator-induced lung injury.
Continuous treatment during ventilation support
Duration - Up to 6 days post treatment
Participants are observed for changes in lung pressures and pulmonary inflammation after device use.
Assessments at 72 and 144 hours post device initiation
Trial Site Locations
Total: 1 location
1
Frankston Hospital
Frankston, Victoria, Australia, 3199
Actively Recruiting
Research Team
R
RAVINDRANATH TIRUVOIPATI, PhD
S
Sachin Gupta, FCICM
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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