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ECCO2R - Mechanical Power Study

U

University of Milan

Status

Unknown

Conditions

Extracorporeal CO2 Removal
ARDS, Human
Mechanical Power

Treatments

Other: Extracorporeal CO2 Removal

Study type

Observational

Funder types

Other

Identifiers

NCT03939260
13175/2019

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Davide Chiumello, Professor

Data sourced from clinicaltrials.gov

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