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

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.

Study Overview

• Status: Recruiting
• Conditions: ARDS, Human
• Intervention / Treatment: Device: Extracorporeal carbon dioxide removal

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: RAVINDRANATH TIRUVOIPATI, PhD; Phone Number: +61431279347; Email: Rtiruvoipati@phcn.vic.gov.au
• Study Contact Backup: Name: Sachin Gupta, FCICM; Email: sachingupta@phcn.vic.gov.au

Study Locations

• Australia
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Recruiting
      • Frankston Hospital
      • Contact: Sachin Gupta, FCICM; Email: sachingupta@phcn.vic.gov.au
      • Contact: Ravindranath Tiruvoipati, PhD; Phone Number: 0431279347; Email: rtiruvoipati@phcn.vic.gov.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (18 years or older) with diagnosis of ARDS

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients (18 years or older) with diagnosis of ARDS as per Berlin Definition	Device: Extracorporeal carbon dioxide removal; Low flow extracorporeal carbon dioxide removal with PrismaLung+

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peninsula Health
• Collaborators: Baxter Healthcare Corporation; Monash University
• Investigators: Principal Investigator: RAVINDRANATH TIRUVOIPATI, PhD, Peninsula Heatlh

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: ECC2R, Carbon dioxide, ventilator induced lung injury
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Respiratory Distress Syndrome; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: 85711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No