Use of Extracorporeal CO2 Removal in Case of Moderate to Severe ARDS to Apply an Ultraprotective Mechanical Ventilation Strategy

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

High-flow extracorporeal CO2 removal

Clinical Study ID

NCT04556578

RECHMPL19-0548

Ages > 18
All Genders

Study Summary

The extracorporeal CO2 removal (ECCO2R) has been recently proposed in case of Acute Respiratory Distress Syndrome (ARDS) in order to reduce pulmonary injuries induced by the mechanical ventilation. A reducing of tidal volume and/or respiratory rate is thus expected using this extracorporeal respiratory support. However, most of existing devices of ECCO2R can apply only a limited extracorporeal flow, often less than 1L/min, which limits the CO2 exchanges and does not allow to reach an ultraprotective ventilation. An extracorporeal flow higher should logically maximalize CO2 removal and allow reducing intensity of mechanical ventilation. Works focused on high-flow ECCO2R (2-3 L/min) in setting of ARDS are therefore mandatory to better understand apprehend the phenomena of gazes changes with this device and confirm the added-value in management of these specific patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Aged from 18 years old
Patient suffering from ARDS including the 3 following parameters during more than 12hours:

PaO2/FiO2 ≤200 Driving Pressure ≥15 cmH2O, Tidal Volume = 6 mL/kg PIT Respiratory rate ≥ 28/min

Or patient hospitalized for severe bronchospasm or COPD exacerbation associating apersistent capnia ≥ 50 mmHg despite maximal mechanical ventilation (Vt = 6mL/kg PIT,respiratory rate ≥ 24/min)

Exclusion

Exclusion Criteria:

Patients protected by law (Art.L 1121-5, 1121-6, 1121-8 du Code de la santépublique)
Consent refusal from the patient or his/her next of kin and the impossibility toenrol using the emergency procedure
Pregnant or breast feeding patient
Absence of a French Health Care Insurance coverage

Study Design

High-flow extracorporeal CO2 removal

February 16, 2021

October 26, 2023

Study Description

This is a prospective interventional study focused on a cohort population.

The included patients will be those affected by a severe ARDS (Berlin definition) requiring an aggressive mechanical ventilation and whom a high-flow ECCO2R was implemented.

The high-flow ECCO2R will be proposed in all patients with inclusions criteria with the 15 first days following their admission. The day of initiation of the high-flow ECCO2R will considered as Day 0 in our study.

A data collection will be focused on the respiratory parameters, clinical complications until ICU discharge and outcome, extracted from medical records.

The main endpoint will be the perrcentage of patients whom an ultraprotective ventilation could be applied successfully during more than 12h. Ultraprotective ventilation is defined in our work as follows: Tidal volume ≤ 3 mL/kg and respiratory rate ≤ 16/min associated with a PaCO2 ≤ 45mmHg and a PaO2 ≥ 55 mmHg.

The secondary endpoints will be durations of mechanical ventilation, ICU stay and hospitalization, as well as rheological behavior of extracorporeal circulation, respiratory parameters under high-flow ECCO2R, specific complications and mortality.

Connect with a study center

University Hospital of Montpellier
Montpellier, 34295
France
Site Not Available

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