ARDS, HumanNCT03939260
ECCO2R - Mechanical Power Study
An observational study of ARDS, Human and Extracorporeal CO2 Removal, run by University of Milan at 1 site in Italy.
Trial summary
Although mechanical ventilation remains the cornerstone of ARDS treatment, several experimental and clinical studies have undoubtedly demonstrated that it can contribute to high mortality through the developing of ventilator induced lung injury even in patients with plateau pressure <30 cmH2O. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human, Extracorporeal CO2 Removal, Mechanical Power
- What is being tested?
- Extracorporeal CO2 Removal
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2019to Mar 2024
- 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: Adult respiratory distress syndrome (ARDS) patients, affected by a life-threatening condition characterized by nonhydrostatic pulmonary edema that can be caused by pulmonary (eg, pneumonia, aspiration) or nonpulmonary (eg, sepsis, pancreatitis, trauma) insults and accounts for 10% of intensive care unit (ICU) admissions. Mortality remains high ranging from 35% to 46% and it has been estimated that at least 150,000 individuals die each year of adult respiratory distress syndrome.
Who may be able to join
- ARDS patients undergoing mechanical ventilation with:
- PaO2/FiO2 <150 with a level of positive end expiratory pressure (PEEP) of 10 cmH2O or higher with a FiO2 > 0.5
- Plateau pressure of 28 cmH2O or higher with tidal volume of 6 ml/Kg of ideal body weight
- Mechanical power of 18 J/min or higher.
Who cannot join
- <18 years of age
- Pregnancy
- Obesity with BMI> 30
- Platelets <30 G/l
- Decompensated heart failure or acute coronary syndrome
- Acute brain injury
Show all 10Show fewer
- Contraindication for systemic anticoagulation (for example, gastrointestinal bleeding, recent cerebrovascular accident, or chronic bleeding disorder, recent major surgery)
- Patient moribund, decision to limit therapeutic interventions
- Catheter access to femoral vein or jugular vein impossible
- Pneumothorax.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ASST-Santi Paolo e Carlo, San Paolo Hospital
Milan, 20142
Davide Chiumello, +390281844020, chiumello@libero.it
About this study
Official title: The Effects of Low Flow Extracorporeal CO2 Removal on Mechanical Power in ARDS Patients
Although mechanical ventilation remains the cornerstone of ARDS treatment, several experimental and clinical studies have undoubtedly demonstrated that it can contribute to high mortality through the developing of ventilator induced lung injury even in patients with plateau pressure <30 cmH2O. Since now there are no studies exploring the application of low flow extracorporeal CO2 removal and ultraprotective ventilation to reduce mechanical power, a composite index of VILI, independently from the value of plateau pressure or the severity of hypercapnia.
- Conditions
- ARDS, Human, Extracorporeal CO2 Removal, Mechanical Power
- Being tested
- Extracorporeal CO2 Removal
- 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.
Extracorporeal CO2 RemovalOther
Extracorporeal carbon dioxide removal (ECCO2R), a low flow extracorporeal CO2 removal, may be used in association with ultraprotective mechanical ventilation (tidal volume < 6 ml/kg and Pplat <20-25 cmH2O).
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Power reduction.
Achievement of Mechanical Power reduction under 18 J/min while maintaining pH and PaCO2 to ± 20% of baseline values obtained at tidal volume of 6 mL/kg.
Mechanical Power (MP) (J/min) = 0.098 * respiratory rate * tidal volume (inspiratory peak airway pressure - 1/2 * (airway pressure at end inspiratory pause - airway pressure at PEEP))
Measured: Changes from baseline to day 5.
Secondary outcomes (8)
Respiratory mechanics.
- Respiratory system elastance (Ers) (cmH2O/L) = (airway pressure at end inspiratory pause - airway pressure at PEEP) / tidal volume
Measured: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Respiratory mechanics.
- Lung elastance (El) (cmH2O/L) = (transpulmonary pressure at end inspiratory pause - transpulmonary pressure at PEEP / tidal volume
Measured: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Respiratory mechanics.
- Chest wall elastance (Ecw) (cmH2O/L) = (esophageal pressure at end inspiratory pause - esophageal pressure at PEEP) / tidal volume
Measured: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Respiratory mechanics.
- End inspiratory transpulmonary pressure (cmH2O)= airway pressure at end inspiratory pause - (esophageal pressure at end inspiratory pause - expiration at atmospheric pressure by a release manouvre).
Measured: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Gas exchange.
Assessment of changes in PaCO2 mmHg.
Measured: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Gas exchange.
Assessment of changes in PaO2 mmHg.
Measured: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Gas exchange.
Assessment of changes in PaO2/FiO2.
Measured: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Safety assessment and adverse device related events: frequency of serious adverse events
Safety assessment reporting frequency of serious adverse events in terms of device related mechanical events (Pump malfunction, membrane lung clotting, system leaks, tubing rupture, air in the circuit) and device related clinical events (heamolysis, significant bleeding, thromboembolic complications, neurologic complications, metabolic complications).
Measured: Every day, until the fifth day or until the weaning from ECCO2R if lower than five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start20 Mar 2019
- Primary completionMar 2021 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ARDS, HumanStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Chiumello, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939260
- Sponsor's protocol ID
- 13175/2019
- Status last verified
- May 2019
- First submitted
- 16 Apr 2019
- Last updated
- 6 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337Fan E, Needham DM, Stewart TE. Ventilatory management of acute lung injury and acute respiratory distress syndrome. JAMA. 2005 Dec 14;294(22):2889-96. doi: 10.1001/jama.294.22.2889.
PubMed 16352797Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Chiumello D, Brochard L, Marini JJ, Slutsky AS, Mancebo J, Ranieri VM, Thompson BT, Papazian L, Schultz MJ, Amato M, Gattinoni L, Mercat A, Pesenti A, Talmor D, Vincent JL. Respiratory support in patients with acute respiratory distress syndrome: an expert opinion. Crit Care. 2017 Sep 12;21(1):240. doi: 10.1186/s13054-017-1820-0.
PubMed 28899408Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
PubMed 27620287Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
PubMed 26872367Kolobow T, Gattinoni L, Tomlinson T, Pierce JE. An alternative to breathing. J Thorac Cardiovasc Surg. 1978 Feb;75(2):261-6.
PubMed 625133Peek GJ, Clemens F, Elbourne D, Firmin R, Hardy P, Hibbert C, Killer H, Mugford M, Thalanany M, Tiruvoipati R, Truesdale A, Wilson A. CESAR: conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure. BMC Health Serv Res. 2006 Dec 23;6:163. doi: 10.1186/1472-6963-6-163.
PubMed 17187683
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low Flow Extracorporeal CO2 Removal on Mechanical Power in ARDS Patients
- ClinicalTrials.gov ID
- NCT03939260
- Acronym / sponsor ID
- 13175/2019
- Conditions
- ARDS, Human, Extracorporeal CO2 Removal, Mechanical Power
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 6 May 2019 (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.
Although mechanical ventilation remains the cornerstone of ARDS treatment, several experimental and clinical studies have undoubtedly demonstrated that it can contribute to high mortality through the developing of ventilator induced lung injury even in patients with plateau pressure <30 cmH2O. Since now there are no studies exploring the application of low flow extracorporeal CO2 removal and ultraprotective ventilation to reduce mechanical power, a composite index of VILI, independently from the value of plateau pressure or the severity of hypercapnia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult respiratory distress syndrome (ARDS) patients, affected by a life-threatening condition characterized by nonhydrostatic pulmonary edema that can be caused by pulmonary (eg, pneumonia, aspiration) or nonpulmonary (eg, sepsis, pancreatitis, trauma) insults and accounts for 10% of intensive care unit (ICU) admissions. Mortality remains high ranging from 35% to 46% and it has been estimated that at least 150,000 individuals die each year of adult respiratory distress syndrome.
Key inclusion criteria (4 listed)
- PaO2/FiO2 <150 with a level of positive end expiratory pressure (PEEP) of 10 cmH2O or higher with a FiO2 > 0.5
- Plateau pressure of 28 cmH2O or higher with tidal volume of 6 ml/Kg of ideal body weight
- Mechanical power of 18 J/min or higher.
Key exclusion criteria (10 listed)
- <18 years of age
- Pregnancy
- Obesity with BMI> 30
- Platelets <30 G/l
- Decompensated heart failure 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 |
|---|---|---|
| Extracorporeal CO2 RemovalExtracorporeal carbon dioxide removal (ECCO2R), a low flow extracorporeal CO2 removal, may be used in association with ultraprotective mechanical ventilation (tidal volume < 6 ml/kg and Pplat <20-25 cmH2O). | Other | – |
Primary outcome
Mechanical Power reduction.
Time frame: Changes from baseline to day 5.
Achievement of Mechanical Power reduction under 18 J/min while maintaining pH and PaCO2 to ± 20% of baseline values obtained at tidal volume of 6 mL/kg. Mechanical Power (MP) (J/min) = 0.098 * respiratory rate * tidal volume (inspiratory peak airway pressure - 1/2 * (airway pressure at end inspiratory pause - airway pressure at PEEP))
8 secondary outcomes
Respiratory mechanics.
Time frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Respiratory mechanics.
Time frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Respiratory mechanics.
Time frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Respiratory mechanics.
Time frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Gas exchange.
Time frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Gas exchange.
Time frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Gas exchange.
Time frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Safety assessment and adverse device related events: frequency of serious adverse events
Time frame: Every day, until the fifth day or until the weaning from ECCO2R if lower than five days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Background: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- Background: PubMed 16352797Fan E, Needham DM, Stewart TE. Ventilatory management of acute lung injury and acute respiratory distress syndrome. JAMA. 2005 Dec 14;294(22):2889-96. doi: 10.1001/jama.294.22.2889.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Background: PubMed 28899408Chiumello D, Brochard L, Marini JJ, Slutsky AS, Mancebo J, Ranieri VM, Thompson BT, Papazian L, Schultz MJ, Amato M, Gattinoni L, Mercat A, Pesenti A, Talmor D, Vincent JL. Respiratory support in patients with acute respiratory distress syndrome: an expert opinion. Crit Care. 2017 Sep 12;21(1):240. doi: 10.1186/s13054-017-1820-0.
- Background: PubMed 27620287Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
- Background: PubMed 26872367Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
- Background: PubMed 625133Kolobow T, Gattinoni L, Tomlinson T, Pierce JE. An alternative to breathing. J Thorac Cardiovasc Surg. 1978 Feb;75(2):261-6.
- Background: PubMed 17187683Peek GJ, Clemens F, Elbourne D, Firmin R, Hardy P, Hibbert C, Killer H, Mugford M, Thalanany M, Tiruvoipati R, Truesdale A, Wilson A. CESAR: conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure. BMC Health Serv Res. 2006 Dec 23;6:163. doi: 10.1186/1472-6963-6-163.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, Human and Extracorporeal CO2 Removal, run by University of Milan at 1 site in Italy.
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 10 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: status not confirmed, as of the sponsor's last update on 6 May 2019. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Davide Chiumello, Professor (+390281844020, chiumello@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical Power reduction. (time frame: Changes from baseline to day 5.). 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 NCT03939260, which also lists 8 linked publications.
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 6 May 2019.