Using a device to remove carbon dioxide to reduce lung injury in ARDS patients
Measuring the Impact of Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury in Mechanically Ventilated Patients
Peninsula Health · NCT06321497
This study tests whether a special device that removes carbon dioxide can help adults with ARDS on ventilators breathe better and reduce lung injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peninsula Health (other gov) |
| Locations | 1 site (Frankston, Victoria) |
| Trial ID | NCT06321497 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the use of extracorporeal carbon dioxide removal (ECCO2R) devices in patients with acute respiratory distress syndrome (ARDS) who are on mechanical ventilation. The study aims to assess whether these devices can effectively reduce hypercapnia and hypercapnic acidosis, which are associated with increased mortality in ventilated patients. By minimizing these conditions, the study seeks to demonstrate a potential reduction in ventilator-induced lung injury. The study will include adult patients diagnosed with ARDS who meet specific respiratory criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with ARDS who exhibit specific respiratory parameters.
Not a fit: Patients with ARDS lasting more than 72 hours or those with life-threatening hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower mortality rates in ARDS patients undergoing mechanical ventilation.
How similar studies have performed: While the use of ECCO2R devices is established, the specific impact on ventilator-induced lung injury remains to be clearly demonstrated, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adult patients (18 years or older) with diagnosis of ARDS as per Berlin Definition21. Driving pressure (ΔP) \> 14 and/or Plateau \>/= 25 (ΔP is calculated using as plateau pressure minus positive end-expiratory pressure)20 Respiratory rate \> 20 breaths per minute pH \< 7.25 and PaCO2 \>45 Exclusion Criteria: ARDS lasting more than 72 hours at the time of inclusion High pressure (Plateau pressure \>30 cm H2O) or high FiO2 (\>0·8) ventilation for more than 168 h (7 days); Life threatening hemodynamic instability as defined by ongoing arrhythmias that is not responsive to treatment Contraindication to limited anticoagulation Treatment limitation including not for resuscitation and not for reintubation Patients with potentially irreversible respiratory failure caused by conditions such as pulmonary fibrosis.
Where this trial is running
Frankston, Victoria
- Frankston Hospital — Frankston, Victoria, Australia (RECRUITING)
Study contacts
- Principal investigator: RAVINDRANATH TIRUVOIPATI, PhD — Peninsula Heatlh
- Study coordinator: RAVINDRANATH TIRUVOIPATI, PhD
- Email: Rtiruvoipati@phcn.vic.gov.au
- Phone: +61431279347
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ARDS, Human, ECC2R, Carbon dioxide, ventilator induced lung injury