ECCO2R - Mechanical Power Study

• Conditions: ARDS, Human; Extracorporeal CO2 Removal; Mechanical Power

• Registration Number: NCT03939260
• Lead Sponsor: University of Milan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-20
• Study First Submitted: 2019-04-16
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-03
• Last Update Submitted: 2019-05-03
• Study First Posted: 2019-05-06
• Last Update Posted: 2019-05-06
• Primary Completion: 2021-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 PaO2/FiO2.
Respiratory mechanics.	Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days	4. End inspiratory transpulmonary pressure (cmH2O)= airway pressure at end inspiratory pause - (esophageal pressure at end inspiratory pause - expiration at atmospheric pressure by a release manouvre).
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).

Trial Locations

Locations (1)

ASST-Santi Paolo e Carlo, San Paolo Hospital; 🇮🇹 Milan, Italy