Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for Moderate ARDS
Recruiting
N/AInterventional Study
Acute Respiratory Distress Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 100
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
230 (estimated)
Sponsor
University of Bologna · Other
Who this trial is looking for
This trial is looking for adults with moderate Acute Respiratory Distress Syndrome (ARDS) who are on mechanical ventilation. If eligible, you may receive a special type of lung support treatment to see if it helps you breathe better.
I have been on mechanical ventilation for 4 days or less
I have a specific level of oxygen in my blood after ventilation
I have low compliance of my respiratory system
I have a high ventilatory ratio
I have lung opacities
I have respiratory failure not due to heart issues
I have not improved with standard ventilation settings
You may not be able to join if
I am pregnant
I have very severe ARDS
I am expected to need mechanical ventilation for less than 2 days
I have severe COPD
I have chronic respiratory issues requiring home oxygen
I currently receive ECMO therapy
I have a severe brain injury
I have had burns covering more than 40% of my body
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 excessiv…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years
* On invasive mechanical ventilation for ≤ 96 hours
* Presence of all of the following conditions for ≤ 24 hours: 100 \< PaO2/FiO2 ≤ 200 after 12 hours of "standardized ventilation" with PEEP ≥ 5; compliance of the respiratory system ≤ 0.5 ml/cmH2O per kg PBW; v…
Inclusion Criteria:
* Age ≥ 18 years
* On invasive mechanical ventilation for ≤ 96 hours
* Presence of all of the following conditions for ≤ 24 hours: 100 \< PaO2/FiO2 ≤ 200 after 12 hours of "standardized ventilation" with PEEP ≥ 5; compliance of the respiratory system ≤ 0.5 ml/cmH2O per kg PBW; ventilatory ratio (VR) ≥ 1.5; bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules; respiratory failure not fully explained by cardiac failure or fluid overload
Exclusion Criteria:
* Pregnancy
* ARDS with PaO2/FiO2\<100 or PaO2/FiO2\>200 under standardized ventilation with PEEP ≥ 5 cmH2O
* Expected duration of mechanical ventilation \< 48 hours
* Severe COPD
* Chronic respiratory insufficiency with home ventilation or oxygen therapy
* Currently receiving ECMO therapy
* Acute brain injury
* Severe liver insufficiency (Child-Pugh scores \>7) or fulminant hepatic failure
* Heparin-induced thrombocytopenia
* Contraindication for systemic anticoagulation
* Platelet count \<50,000/mm3
* Prothrombin time-international normalized ratio (INR) \>1.5
* Patient moribund, decision to limit therapeutic interventions
* End-stage disease
* Unable to provide vascular access for ECCO2-R
* Acute coronary syndrome
* Actual body weight exceeding 1 kg per centimeter of height
* Burns \> 40% total body surface
* Bone marrow transplantation within the last 1 year
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.