Acute Respiratory Distress SyndromeNCT02606240
Low-Flow CO2 Removal for Mild to Moderate ARDS With PRISMALUNG
An observational study of Acute Respiratory Distress Syndrome, run by Groupe Hospitalier Pitie-Salpetriere at 5 sites in France.
Trial summary
This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- CO2 removal with PRISMALUNG in ARDS
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 5 sitesFrance
- Study dates
- Mar 2016to Jun 2017
- Phase
- Observational
- 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
Study population: Mild to Moderate ARDS according to the Berlin definition of ARDS
Who may be able to join
- Mechanical ventilation with expected duration of >24 hours
- Mild to moderate Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: 100 mmHg <PaO2/FiO2 <300 mmHg, with PEEP > 5 cmH2O
Who cannot join
- Age <18 years
- Pregnancy
- Severe hypoxemia with PaO2/FiO2 <100 mmHg
- Body mass index > 40 kg/m2
- Decompensated heart insufficiency or acute coronary syndrome
- Severe Chronic obstructive pulmonary disease (COPD)
Show all 16Show fewer
- Major respiratory acidosis with PaCO2 >60 mmHg
- Acute brain injury
- Severe liver insufficiency (Child-Pugh scores >7) or fulminant hepatic failure
- Heparin-induced thrombocytopenia
- Contraindication for systemic anticoagulation
- Patient moribund, decision to limit therapeutic interventions
- Catheter access to femoral vein or jugular vein impossible
- Pneumothorax
- Platelet <50 G/L
- Lacking consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU AMIENS, Département Anesthésie Réanimation
Amiens
CHU Besançon, Réanimation
Besançon
CHU CLERMONT FERRAND, Département Anesthésie Réanimation
Clermont-Ferrand
CHU MONTPELLIER, Département Anesthésie Réanimation
Montpellier
Hopital Pitié Salpetriere, Reanimation Medicale
Paris, 75013
About this study
Official title: Extracorporeal CO2 Removal (ECCO2R) With a Renal Replacement Platform (PRISMALUNG) to Enhance Lung Protective Ventilation in Patients With Mild to Moderate Acute Respiratory Distress Syndrome (ARDS)
This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.
Read the detailed description
Extracorporeal CO2 removal (ECCO2R) with a low-flow CO2 removal device (Prismalung, Gambro-Baxter) integrated on the Prismaflex platform (Gambro-Baxter) allows tidal volume (Vt) and plateau pressure reduction in patients with mild to moderate ARDS. This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of ECCO2R following Vt and plateau pressure reduction in patients with mild to moderate ARDS. Safety variables during treatment will also be analyzed. A series of 20 consecutive patients will be included in this observational study.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- CO2 removal with PRISMALUNG in ARDS
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 removal with PRISMALUNG in ARDSDevice
Observational study of patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS) submitted to Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device to allow ultraprotective mechanical ventilation with tidal volume reduction (from 6 to 4 ml/kg, predicted body weight) and plateau pressure reduction from 28-30 to 23-25 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| Mild to Moderate ARDS on PRISMALUNG | Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device in patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS). Receives: Device: CO2 removal with PRISMALUNG in ARDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg.
Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg.
Measured: 24 hours
Secondary outcomes (8)
Assessment of changes in Vt
Assessment of changes in Vt
Measured: 24 hours
Assessment of changes in Plateau Pressure
Assessment of changes in Plateau Pressure
Measured: 24 hours
Assessment of changes in respiratory rate
Assessment of changes in respiratory rate
Measured: 24 hours
Assessment of changes in Positive End-Expiratory Pressure, PEEP
Assessment of changes in Positive End-Expiratory Pressure, PEEP
Measured: 24 hours
Change in vasopressor use
Epineprine and norepinephine dose, mcg/kg/min
Measured: 24 hours
Evaluation of lung recruitment/derecruitment
With lung echography. Ccording to the method described by Bouhemad et al, Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7
Measured: 24 hours
Lifetime of the extracorporeal circulation
In hours
Measured: 7 days
Number of participants with adverse events directly related to ECCO2R
Adverse events directly related to ECCO2R are hemolysis (serum free hemoglobin >500 mg/L), infection at the cannulation site, Hemorrhage at the cannulation site, air entry in the circuit.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire, Amiens, Centre Hospitalier Universitaire de Besancon, University Hospital, Clermont-Ferrand, University Hospital, Montpellier
- Responsible party
- Principal investigator, Alain COMBES, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606240
- Sponsor's protocol ID
- PSL-AC-11-11-15
- Status last verified
- Aug 2017
- First submitted
- 11 Nov 2015
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Schmidt M, Jaber S, Zogheib E, Godet T, Capellier G, Combes A. Feasibility and safety of low-flow extracorporeal CO2 removal managed with a renal replacement platform to enhance lung-protective ventilation of patients with mild-to-moderate ARDS. Crit Care. 2018 May 10;22(1):122. doi: 10.1186/s13054-018-2038-5.
PubMed 29743094
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal CO2 Removal (ECCO2R) With a Renal Replacement Platform (PRISMALUNG) to Enhance Lung Protective Ventilation in Patients With Mild to Moderate Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT02606240
- Acronym / sponsor ID
- PSL-AC-11-11-15
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire, Amiens, Centre Hospitalier Universitaire de Besancon, University Hospital, Clermont-Ferrand, University Hospital, Montpellier
- Study start
- Mar 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 17 Nov 2015 (estimated)
- 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.
This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.
Detailed description
Extracorporeal CO2 removal (ECCO2R) with a low-flow CO2 removal device (Prismalung, Gambro-Baxter) integrated on the Prismaflex platform (Gambro-Baxter) allows tidal volume (Vt) and plateau pressure reduction in patients with mild to moderate ARDS. This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of ECCO2R following Vt and plateau pressure reduction in patients with mild to moderate ARDS. Safety variables during treatment will also be analyzed. A series of 20 consecutive patients will be included in this observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild to Moderate ARDS on PRISMALUNG | – | Device: CO2 removal with PRISMALUNG in ARDSExtracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device in patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mild to Moderate ARDS according to the Berlin definition of ARDS
Key inclusion criteria (2 listed)
- Mechanical ventilation with expected duration of >24 hours
- Mild to moderate Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: 100 mmHg <PaO2/FiO2 <300 mmHg, with PEEP > 5 cmH2O
Key exclusion criteria (16 listed)
- Age <18 years
- Pregnancy
- Severe hypoxemia with PaO2/FiO2 <100 mmHg
- Body mass index > 40 kg/m2
- Decompensated heart insufficiency or acute coronary syndrome
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 |
|---|---|---|
| CO2 removal with PRISMALUNG in ARDSObservational study of patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS) submitted to Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device to allow ultraprotective mechanical ventilation with tidal volume reduction (from 6 to 4 ml/kg, predicted body weight) and plateau pressure reduction from 28-30 to 23-25 cmH2O. | Device | Mild to Moderate ARDS on PRISMALUNG |
Primary outcome
Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg.
Time frame: 24 hours
Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg.
8 secondary outcomes
Assessment of changes in Vt
Time frame: 24 hours
Assessment of changes in Plateau Pressure
Time frame: 24 hours
Assessment of changes in respiratory rate
Time frame: 24 hours
Assessment of changes in Positive End-Expiratory Pressure, PEEP
Time frame: 24 hours
Change in vasopressor use
Time frame: 24 hours
Evaluation of lung recruitment/derecruitment
Time frame: 24 hours
Lifetime of the extracorporeal circulation
Time frame: 7 days
Number of participants with adverse events directly related to ECCO2R
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Derived from this study: PubMed 29743094Schmidt M, Jaber S, Zogheib E, Godet T, Capellier G, Combes A. Feasibility and safety of low-flow extracorporeal CO2 removal managed with a renal replacement platform to enhance lung-protective ventilation of patients with mild-to-moderate ARDS. Crit Care. 2018 May 10;22(1):122. doi: 10.1186/s13054-018-2038-5.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by Groupe Hospitalier Pitie-Salpetriere at 5 sites 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 2 inclusion and 16 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: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02606240, which also lists 1 linked publication.
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 8 Aug 2017.