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Clinical Trials/NCT06321497
NCT06321497
Recruiting
Not Applicable

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

Peninsula Health1 site in 1 country15 target enrollmentFebruary 5, 2024
ConditionsARDS, Human

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS, Human
Sponsor
Peninsula Health
Enrollment
15
Locations
1
Primary Endpoint
Reduction in driving airway pressures
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 5, 2024
End Date
February 28, 2028
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Outcomes

Primary Outcomes

Reduction in driving airway pressures

Time Frame: 72 and 144 hours post initiation of ECCO2R

Secondary Outcomes

  • Reduction in pulmonary inflammation assessed by interleukins in lung(72 and 144 hours post initiation of ECCO2R)

Study Sites (1)

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