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NCT Number: NCT06321497

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

Lung protective ventilation with low tidal volumes and low driving pressure are known to reduce mortality in mechanically ventilated patients with acute respiratory failure. This reduction in mortality is known be due to reduction of ventilator induced lung injury that occurs due to high tidal volumes and high driving pressure. When receiving such mechanical ventilation, some patients develop hypercapnia and associated hypercapnic acidosis. Such patients have an increased risk of mortality. While the exact reasons for such increase in mortality is not known, it is recommended to minimise hypercapnia and hypercapnic acidosis during lung protective ventilation. Minimally invasive extracorporeal carbon dioxide removal (ECCO2R) devices are shown to reduce hypercapnia and hypercapnic acidosis. There are several devices that are currently available in the current clinical practice. However, the effect of these devices on reduction in ventilator induced lung injury is not clearly demonstrated. This study aims to assess the use of an ECCO2R device called Prismalung in reducing ventilator induced lung injury. PrismaLung is currently used in our intensive care unit. This assessment is done by measuring interleukins in bronchoalveolar lavage fluid and blood interleukin levels as well as clinical assessment including the reduction of driving pressure.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal carbon dioxide removal

Device

Low flow extracorporeal carbon dioxide removal with PrismaLung+

Primary outcomes

  1. Reduction in driving airway pressures

    Time frame: 72 and 144 hours post initiation of ECCO2R

Secondary outcomes

  1. Reduction in pulmonary inflammation assessed by interleukins in lung

    Time frame: 72 and 144 hours post initiation of ECCO2R

Study contacts

Contact information is provided by the study sponsor or research team.

RAVINDRANATH TIRUVOIPATI, PhD

CONTACT

[email protected]

+61431279347

Sachin Gupta, FCICM

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Peninsula Health

Other Gov

Collaborators

  • Baxter Healthcare Corporation
  • Monash University

Registry information

Official study title

Measuring the Impact of Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury in Mechanically Ventilated Patients

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 20, 2024
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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