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

Primary Purpose

Acue Respiratory Distress Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High-flow extracorporeal CO2 removal
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acue Respiratory Distress Syndrome focused on measuring ARDS, ECCO2R, Ultraprotective ventilation, Respiratory extracorporeal support, Mechanical power, Driving pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital of MontpellierRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High-flow ECCO2R

Arm Description

Extracorporeal support using high flow circulation

Outcomes

Primary Outcome Measures

percentage of patient who obtained a safe ultraprotective ventilation
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
Hospital length of stay
ICU length of stay
Day 30 all-cause mortality

Full Information

First Posted
September 14, 2020
Last Updated
February 6, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT04556578
Brief Title
Use of Extracorporeal CO2 Removal in Case of Moderate to Severe ARDS to Apply an Ultraprotective Mechanical Ventilation Strategy
Acronym
ECCO2R
Official Title
Use of Extracorporeal CO2 Removal in Case of Moderate to Severe Acute Respiratory Distress Syndrome to Apply an Ultraprotective Mechanical Ventilation Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
February 16, 2025 (Anticipated)
Study Completion Date
February 16, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acue Respiratory Distress Syndrome
Keywords
ARDS, ECCO2R, Ultraprotective ventilation, Respiratory extracorporeal support, Mechanical power, Driving pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-flow ECCO2R
Arm Type
Experimental
Arm Description
Extracorporeal support using high flow circulation
Intervention Type
Procedure
Intervention Name(s)
High-flow extracorporeal CO2 removal
Intervention Description
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.
Primary Outcome Measure Information:
Title
percentage of patient who obtained a safe ultraprotective ventilation
Description
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.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation
Time Frame
up to Day 30
Title
Hospital length of stay
Time Frame
up to Day 30
Title
ICU length of stay
Time Frame
up to Day 30
Title
Day 30 all-cause mortality
Time Frame
up to Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Charbit, MD
Phone
+33467338256
Email
j-charbit@chu-montpellier.fr
Facility Information:
Facility Name
University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jonathan CHARBIT, MD
Phone
+33467338256
Email
j-charbit@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Jonathan CHARBIT, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected
IPD Sharing Time Frame
12 months after the main publication
IPD Sharing Access Criteria
Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.

Learn more about this trial

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

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