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

NCT ID: NCT04556578

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-16
• Study Completion Date: 2023-10-26

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.

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.

Conditions

Acue Respiratory Distress Syndrome

Keywords

ARDS; ECCO2R; Ultraprotective ventilation; Respiratory extracorporeal support; Mechanical power; Driving pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High-flow ECCO2R

Extracorporeal support using high flow circulation

Group Type: EXPERIMENTAL

High-flow extracorporeal CO2 removal

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Montpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL19-0548

Identifier Type: -

Identifier Source: org_study_id