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

Recruiting

• Conditions: ARDS, Human
• Interventions: Device: Extracorporeal carbon dioxide removal

• Registration Number: NCT06321497
• Lead Sponsor: Peninsula Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study Start: 2024-02-05
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Last Update Submitted: 2024-03-13
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20
• Primary Completion: 2027-02-28
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients (18 years or older) with diagnosis of ARDS as per Berlin Definition	Extracorporeal carbon dioxide removal	-

Primary Outcome Measures

Name	Time	Method
Reduction in driving airway pressures	72 and 144 hours post initiation of ECCO2R

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Frankston Hospital; 🇦🇺 Frankston, Victoria, Australia