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Search / Trial NCT06321497

Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury

Launched by PENINSULA HEALTH · Mar 13, 2024

Trial Information

Current as of September 05, 2025

Recruiting

Keywords

Ecc2 R, Carbon Dioxide, Ventilator Induced Lung Injury

ClinConnect Summary

This clinical trial is studying a device called PrismaLung, which is designed to help remove excess carbon dioxide from the blood in patients with Acute Respiratory Distress Syndrome (ARDS). The goal is to see if using this device can reduce lung injury that sometimes happens when patients are on mechanical ventilation, especially when high pressures are used to help them breathe. By using PrismaLung, researchers hope to improve patients' lung health and overall outcomes.

Eligible participants for this trial include adults aged 18 and older who have been diagnosed with ARDS and are experiencing certain breathing challenges, such as high driving pressure in their lungs. Patients who have been on a ventilator for too long or have certain severe health conditions may not be able to participate. If someone joins the study, they can expect regular monitoring and assessments to measure how well their lungs are responding to the treatment. This trial is currently recruiting participants, and involvement could provide valuable insights into improving care for patients with ARDS.

Gender

ALL

Eligibility 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.

About Peninsula Health

Peninsula Health is a leading integrated health service provider located in the southeastern region of Melbourne, Australia. Committed to delivering high-quality, patient-centered care, Peninsula Health encompasses a range of facilities, including hospitals, community services, and rehabilitation programs. The organization actively engages in clinical research and trials, aiming to advance medical knowledge and improve health outcomes for the diverse populations it serves. With a focus on innovation and collaboration, Peninsula Health is dedicated to fostering a culture of research excellence and translating findings into practical healthcare solutions.

Locations

Frankston, Victoria, Australia

Patients applied

0 patients applied

Trial Officials

RAVINDRANATH TIRUVOIPATI, PhD

Principal Investigator

Peninsula Heatlh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported