Clinical trial NCT03939260: ECCO2R - Mechanical Power Study
Official title: The Effects of Low Flow Extracorporeal CO2 Removal on Mechanical Power in ARDS Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS, Human
Extracorporeal CO2 Removal
Mechanical Power
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult respiratory distress syndrome (ARDS) patients, affected by a life-threatening condition characterized by nonhydrostatic pulmonary edema that can be caused by pulmonary (eg, pneumonia, aspiration) or nonpulmonary (eg, sepsis, pancreatitis, trauma) insults and accounts for 10% of intensive care unit (ICU) admissions. Mortality remains high ranging from 35% to 46% and it has been estimated that at least 150,000 individuals die each year of adult respiratory distress syndrome.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mechanical Power reduction.
timeFrame: Changes from baseline to day 5.
Secondary outcomes:
measure: Respiratory mechanics.
timeFrame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
measure: Respiratory mechanics.
timeFrame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
measure: Respiratory mechanics.
timeFrame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
measure: Respiratory mechanics.
timeFrame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
measure: Gas exchange.
timeFrame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
measure: Gas exchange.
timeFrame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
measure: Gas exchange.
timeFrame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
measure: Safety assessment and adverse device related events: frequency of serious adverse events
timeFrame: Every day, until the fifth day or until the weaning from ECCO2R if lower than five days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ASST-Santi Paolo e Carlo, San Paolo Hospital
Study officials:
References:
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citation: Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
citation: Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
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