Skip to content

Carbon dioxide removal with PrismaLung in patients with respiratory failure in intensive care unit.

Measuring the impact of extracorporeal carbon dioxide removal using PrismaLung on ventilator induced lung injury in mechanically ventilated patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624000070538
Enrollment
15
Registered
2024-01-29
Start date
2024-02-05
Completion date
2026-01-31
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Some patients when receiving such mechanical ventilation develop hypercapnia and associated hypercapnic acidosis. Such patients have an increased risk of mortality. While the exact reasons of 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 reduction in ventilator induced lung injury with the use of ECCO2R device called Prismalung that is currently used in our intensive care unit. This assessment is done by measuring of pulmonary interleukins and blood interleukin levels as well as clinical assessment including the reduction of driving pressure.

Interventions

No specific exposure intervention that will be evaluated in this study. It investigates how effective is the intervention (ECCO2R with PrismaLung) that is being used on the patient in reducing the lung injury known to associated with mechanical ventilation. This study includes patients already receiving ECCO2R with PrismaLung as part of their standard mechanical ventilation treatment, Driving pressures on the ventilator prior to initiation of PrismaLung will be compared with the driving pressur

No specific exposure intervention that will be evaluated in this study. It investigates how effective is the intervention (ECCO2R with PrismaLung) that is being used on the patient in reducing the lung injury known to associated with mechanical ventilation. This study includes patients already receiving ECCO2R with PrismaLung as part of their standard mechanical ventilation treatment, Driving pressures on the ventilator prior to initiation of PrismaLung will be compared with the driving pressures while the patients are receiving PrismaLung for up to 144 hours. Arterial blood gasses and cytokine profile will be compared prior to initiation and after initiation of PrismaLung for up to 144 hours. All data will be available from the medical records.

Sponsors

Peninsula Health
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adult patients (18 years or older) with diagnosis of ARDS as per the Berlin Definition.(Ref Acute Respiratory Distress Syndrome: The Berlin Definition. JAMA. 2012; 307: 2526-33.) 2. Driving pressure ( P) > 14 and/or Plateau >/= 25 (P is calculated using as plateau pressure minus positive end-expiratory pressure). (Ref: Combes A, Auzinger G, Capellier G, et al. ECCO2R therapy in the ICU: consensus of a European round table meeting. Critical Care. 2020; 24: 490) 3. Respiratory rate > 20 breaths per minute 4. pH < 7.25 and PaCO2 >45

Exclusion criteria

1. ARDS lasting more than 72 hours at the time of inclusion 2. High pressure (Plateau pressure >30 cm H2O) or high FiO2 (>0·8) ventilation for more than 168 h (7 days); 3. Severe hemodynamic instability as defined by ongoing arrhythmias that is not responsive to treatment 4 Contraindication to limited anticoagulation 5. Treatment limitation including not for resuscitation and not for reintubation 6. Patients with potentially irreversible respiratory failure

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026