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Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for Moderate ARDS

NCT04903262 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2025-04-02

No results posted yet for this study

Summary

Acute respiratory distress syndrome (ARDS) accounts for 10% of all ICU admissions and for 23% of patients requiring mechanical ventilation (MV). Its hospital mortality remains high, ranging from 34% in mild forms up to 46% in severe cases. Positive pressure MV remains the cornerstone of management, but at the same time it can contribute to worsening and maintenance of the lung injury when excessive stress and strain is applied to the lung parenchima (so-called ventilator-induced lung injury, VILI). VILI significantly contributes to the morbidity and mortality of ARDS patients, and it has been clearly demonstrated that protective (low-volume, low-pressure) MV settings are associated with a significant survival benefit. Unfortunately, in a certain proportion of ARDS cases, it is difficult to preserve acceptable gas exchange while maintaining protective ventilation settings, due to a high ventilatory load. In these cases, extracorporeal CO2 removal (ECCO2R) can be applied to grant the application of protective or even ultra-protective mechanical ventilation settings.

The main outcome of this multicenter, prospective, randomized, comparative open trial is to determine whether early ECCO2R allowing ultraprotective mechanical ventilation improves the outcomes of patients with moderate ARDS.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

PROCEDURE

Ultraprotective ventilation with Extracorporeal CO2 removal

HLS5.0 Cardiohelp® (Getinge Cardiopulmonary Care, Rastatt, Germany): 1.3 m² polymethylpentene hollow fiber membrane oxygenator. The extracorporeal blood flow is in the range of 1000 to 1500 mL/min. Sweep gas (air or oxygen) is drawn through the hollow fibers by a vacuum pump, creating a diffusion gradient for gas exchange across the membrane.

PROCEDURE

Conventional protective ventilation

Conventional lung protective mechanical ventilation, as described in the arm description ("standardized ventilation")

Sponsors & Collaborators

  • Getinge Group

    collaborator OTHER

  • University of Bologna

    lead OTHER

Principal Investigators

  • Marco Ranieri, M.D. · University of Bari

  • Antonio Pesenti, M.D. · University of Milan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04903262 on ClinicalTrials.gov