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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06321497

Enrollment

Registered

2024-03-20

Start date

2024-02-05

Completion date

2028-02-28

Last updated

2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Human

Keywords

ECC2R, Carbon dioxide, ventilator induced lung injury

Brief summary

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.

Interventions

DEVICEExtracorporeal carbon dioxide removal

Low flow extracorporeal carbon dioxide removal with PrismaLung+

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Reduction in driving airway pressures	72 and 144 hours post initiation of ECCO2R

Secondary

Measure	Time frame
Reduction in pulmonary inflammation assessed by interleukins in lung	72 and 144 hours post initiation of ECCO2R

Countries

Australia

Contacts

Primary ContactRAVINDRANATH TIRUVOIPATI, PhD

Rtiruvoipati@phcn.vic.gov.au+61431279347

Backup ContactSachin Gupta, FCICM

sachingupta@phcn.vic.gov.au

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026