ECCO2R: Use of Extracorporeal CO2 Removal in Case of Moderate to Severe ARDS to Apply an Ultraprotective Mechanical Ventilation Strategy

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Recruiting

CT.gov ID

NCT04556578

Collaborator

(none)

Enrollment

Location

Arm

20.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acue Respiratory Distress Syndrome	Procedure: High-flow extracorporeal CO2 removal	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Use of Extracorporeal CO2 Removal in Case of Moderate to Severe Acute Respiratory Distress Syndrome to Apply an Ultraprotective Mechanical Ventilation Strategy

Actual Study Start Date :

Feb 16, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-flow ECCO2R Extracorporeal support using high flow circulation	Procedure: High-flow extracorporeal CO2 removal Applying of a CO2 removal using an extracorporeal circulation with a flow of 2-3.5L/min in order to reduce the aggression induced by the mechanical ventilation.

Arm

Intervention/Treatment

Experimental: High-flow ECCO2R

Extracorporeal support using high flow circulation

Procedure: High-flow extracorporeal CO2 removal

Applying of a CO2 removal using an extracorporeal circulation with a flow of 2-3.5L/min in order to reduce the aggression induced by the mechanical ventilation.

Outcome Measures

Primary Outcome Measures

percentage of patient who obtained a safe ultraprotective ventilation [12 hours]
a safe ultraprotective ventilation is defined by the four following parameters : Tidal Volume ≤ 3 mL/kg Respiratory Rate ≤ 16/min PaCO2 ≤ 45mmHg PaO2 ≥ 55 mmHg.

Secondary Outcome Measures

Duration of mechanical ventilation [up to Day 30]
Hospital length of stay [up to Day 30]
ICU length of stay [up to Day 30]
Day 30 all-cause mortality [up to Day 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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

Exclusion Criteria:

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