Low-Flow CO2 Removal for Mild to Moderate ARDS With PRISMALUNG

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

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-06-30

Brief Summary

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This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.

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Detailed Description

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Extracorporeal CO2 removal (ECCO2R) with a low-flow CO2 removal device (Prismalung, Gambro-Baxter) integrated on the Prismaflex platform (Gambro-Baxter) allows tidal volume (Vt) and plateau pressure reduction in patients with mild to moderate ARDS. This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of ECCO2R following Vt and plateau pressure reduction in patients with mild to moderate ARDS. Safety variables during treatment will also be analyzed. A series of 20 consecutive patients will be included in this observational study.

Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mild to Moderate ARDS on PRISMALUNG

Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device in patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS).

CO2 removal with PRISMALUNG in ARDS

Intervention Type DEVICE

Observational study of patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS) submitted to Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device to allow ultraprotective mechanical ventilation with tidal volume reduction (from 6 to 4 ml/kg, predicted body weight) and plateau pressure reduction from 28-30 to 23-25 cmH2O.

Interventions

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CO2 removal with PRISMALUNG in ARDS

Observational study of patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS) submitted to Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device to allow ultraprotective mechanical ventilation with tidal volume reduction (from 6 to 4 ml/kg, predicted body weight) and plateau pressure reduction from 28-30 to 23-25 cmH2O.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Mechanical ventilation with expected duration of \>24 hours
* Mild to moderate Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: 100 mmHg \<PaO2/FiO2 \<300 mmHg, with PEEP \> 5 cmH2O

Exclusion Criteria

* Age \<18 years
* Pregnancy
* Severe hypoxemia with PaO2/FiO2 \<100 mmHg
* Body mass index \> 40 kg/m2
* Decompensated heart insufficiency or acute coronary syndrome
* Severe Chronic obstructive pulmonary disease (COPD)
* Major respiratory acidosis with PaCO2 \>60 mmHg
* Acute brain injury
* Severe liver insufficiency (Child-Pugh scores \>7) or fulminant hepatic failure
* Heparin-induced thrombocytopenia
* Contraindication for systemic anticoagulation
* Patient moribund, decision to limit therapeutic interventions
* Catheter access to femoral vein or jugular vein impossible
* Pneumothorax
* Platelet \<50 G/L
* Lacking consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No