Acue Respiratory Distress SyndromeECCO2RNCT04556578
Use of Extracorporeal CO2 Removal in Case of Moderate to Severe ARDS to Apply an Ultraprotective Mechanical Ventilation Strategy
A study testing High-flow extracorporeal CO2 removal in people with Acue Respiratory Distress Syndrome, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acue Respiratory Distress Syndrome
- What is being tested?
- High-flow extracorporeal CO2 removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2021to 26 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Extracorporeal CO2 Removal in Case of Moderate to Severe Acute Respiratory Distress Syndrome to Apply an Ultraprotective Mechanical Ventilation Strategy
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.
Read the 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
- Being tested
- High-flow extracorporeal CO2 removal
- Keywords
- ARDS, ECCO2R, Ultraprotective ventilation, Respiratory extracorporeal support, Mechanical power, Driving pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow extracorporeal CO2 removalProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| High-flow ECCO2R | Experimental | Extracorporeal support using high flow circulation Receives: Procedure: High-flow extracorporeal CO2 removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 hours
Secondary outcomes (4)
Duration of mechanical ventilation
Measured: up to Day 30
Hospital length of stay
Measured: up to Day 30
ICU length of stay
Measured: up to Day 30
Day 30 all-cause mortality
Measured: up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start16 Feb 2021
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
Why it stopped: change in current practice in intensive care, few inclusions achievable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acue Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556578
- Sponsor's protocol ID
- RECHMPL19-0548
- Acronym
- ECCO2R
- Status last verified
- Dec 2024
- First submitted
- 14 Sep 2020
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Extracorporeal CO2 Removal in Case of Moderate to Severe Acute Respiratory Distress Syndrome to Apply an Ultraprotective Mechanical Ventilation Strategy
- ClinicalTrials.gov ID
- NCT04556578
- Acronym / sponsor ID
- ECCO2R / RECHMPL19-0548
- Conditions
- Acue Respiratory Distress Syndrome
- Keywords
- ARDS, ECCO2R, Ultraprotective ventilation, Respiratory extracorporeal support, Mechanical power, Driving pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: change in current practice in intensive care, few inclusions achievable
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-flow ECCO2R | Experimental | Procedure: High-flow extracorporeal CO2 removalExtracorporeal support using high flow circulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-flow extracorporeal CO2 removalApplying 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. | Procedure or surgery | High-flow ECCO2R |
Primary outcome
percentage of patient who obtained a safe ultraprotective ventilation
Time frame: 12 hours
a safe ultraprotective ventilation is defined by the four following parameters : 1. Tidal Volume ≤ 3 mL/kg 2. Respiratory Rate ≤ 16/min 3. PaCO2 ≤ 45mmHg 4. PaO2 ≥ 55 mmHg.
4 secondary outcomes
Duration of mechanical ventilation
Time frame: up to Day 30
Hospital length of stay
Time frame: up to Day 30
ICU length of stay
Time frame: up to Day 30
Day 30 all-cause mortality
Time frame: up to Day 30
Results and safety
The study was stopped early (reason given: change in current practice in intensive care, few inclusions achievable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Yes. identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow extracorporeal CO2 removal in people with Acue Respiratory Distress Syndrome, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: change in current practice in intensive care, few inclusions achievable). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patient who obtained a safe ultraprotective ventilation (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.