ARDS, Human, Extracorporeal CO2 Removal, Mechanical Power
Conditions
Brief summary
Although mechanical ventilation remains the cornerstone of ARDS treatment, several experimental and clinical studies have undoubtedly demonstrated that it can contribute to high mortality through the developing of ventilator induced lung injury even in patients with plateau pressure \<30 cmH2O. Since now there are no studies exploring the application of low flow extracorporeal CO2 removal and ultraprotective ventilation to reduce mechanical power, a composite index of VILI, independently from the value of plateau pressure or the severity of hypercapnia.
Interventions
OTHERExtracorporeal CO2 Removal
Extracorporeal carbon dioxide removal (ECCO2R), a low flow extracorporeal CO2 removal, may be used in association with ultraprotective mechanical ventilation (tidal volume \< 6 ml/kg and Pplat \<20-25 cmH2O).
Sponsors
University of Milan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ARDS patients undergoing mechanical ventilation with: * PaO2/FiO2 \<150 with a level of positive end expiratory pressure (PEEP) of 10 cmH2O or higher with a FiO2 \> 0.5 * Plateau pressure of 28 cmH2O or higher with tidal volume of 6 ml/Kg of ideal body weight * Mechanical power of 18 J/min or higher.
Exclusion criteria
* \<18 years of age * Pregnancy * Obesity with BMI\> 30 * Platelets \<30 G/l * Decompensated heart failure or acute coronary syndrome * Acute brain injury * Contraindication for systemic anticoagulation (for example, gastrointestinal bleeding, recent cerebrovascular accident, or chronic bleeding disorder, recent major surgery) * Patient moribund, decision to limit therapeutic interventions * Catheter access to femoral vein or jugular vein impossible * Pneumothorax.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Power reduction. | Changes from baseline to day 5. | Achievement of Mechanical Power reduction under 18 J/min while maintaining pH and PaCO2 to ± 20% of baseline values obtained at tidal volume of 6 mL/kg. Mechanical Power (MP) (J/min) = 0.098 \* respiratory rate \* tidal volume (inspiratory peak airway pressure - 1/2 \* (airway pressure at end inspiratory pause - airway pressure at PEEP)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory mechanics. | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days | 1\. Respiratory system elastance (Ers) (cmH2O/L) = (airway pressure at end inspiratory pause - airway pressure at PEEP) / tidal volume |
| Gas exchange. | Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days | Assessment of changes in PaCO2 mmHg. |
| Safety assessment and adverse device related events: frequency of serious adverse events | Every day, until the fifth day or until the weaning from ECCO2R if lower than five days | Safety assessment reporting frequency of serious adverse events in terms of device related mechanical events (Pump malfunction, membrane lung clotting, system leaks, tubing rupture, air in the circuit) and device related clinical events (heamolysis, significant bleeding, thromboembolic complications, neurologic complications, metabolic complications). |
Countries
Italy
Contacts
Primary ContactDavide Chiumello, Professor
Outcome results
None listed