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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-05

Study Completion Date

2028-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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ARDS, Human

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Extracorporeal carbon dioxide removal

Intervention Type DEVICE

Low flow extracorporeal carbon dioxide removal with PrismaLung+

Interventions

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Extracorporeal carbon dioxide removal

Low flow extracorporeal carbon dioxide removal with PrismaLung+

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No