Clinical trial NCT06321497: Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury
Official title: Measuring the Impact of Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury in Mechanically Ventilated Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ARDS, Human
Keywords: ECC2R, Carbon dioxide, ventilator induced lung injury
Lead sponsor: Peninsula Health
Sponsor class: OTHER_GOV
Collaborators: name: Monash University
name: Baxter Healthcare Corporation
First posted: 2024-03-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (18 years or older) with diagnosis of ARDS

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.


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.

Primary outcomes:
measure: Reduction in driving airway pressures
timeFrame: 72 and 144 hours post initiation of ECCO2R
Secondary outcomes:
measure: Reduction in pulmonary inflammation assessed by interleukins in lung
timeFrame: 72 and 144 hours post initiation of ECCO2R
Other outcomes:
Locations:
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
Study officials:
affiliation: Peninsula Heatlh
name: RAVINDRANATH TIRUVOIPATI, PhD
role: PRINCIPAL_INVESTIGATOR
References: