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

ARDS, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321497
• Other study ID #: 85711
• Status: Recruiting
• Start date: February 5, 2024
• Est. completion date: February 28, 2028

Study information

• Verified date: December 2023
• Source: Peninsula Health
• Contact: RAVINDRANATH TIRUVOIPATI, PhD
• Phone: +61431279347
• Email: Rtiruvoipati[@]phcn.vic.gov.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 28, 2028
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adult patients (18 years or older) with diagnosis of ARDS as per Berlin Definition21.

Driving pressure (?P) > 14 and/or Plateau >/= 25 (?P 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.

Related Conditions & MeSH terms

• ARDS, Human
• Lung Injury
• Respiratory Distress Syndrome
• Ventilator-Induced Lung Injury

Intervention

Device:
• Extracorporeal carbon dioxide removal
Low flow extracorporeal carbon dioxide removal with PrismaLung+

Locations

Country	Name	City	State
Australia	Frankston Hospital	Frankston	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Peninsula Health	Baxter Healthcare Corporation, Monash University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in driving airway pressures		72 and 144 hours post initiation of ECCO2R
Secondary	Reduction in pulmonary inflammation assessed by interleukins in lung		72 and 144 hours post initiation of ECCO2R