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The study´s intention is to evaluate the feasibility, safety and effectiveness of a pump driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid intubation and invasive mechanical ventilation in patients with acute respiratory failure retaining carbon dioxide due to the failure of their ventilatory muscle pump and not responding to prior non-invasive mask ventilation.
The study´s intention is to evaluate the feasibility, safety and effectiveness of a pump driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid intubation and invasive mechanical ventilation in patients with acute respiratory failure retaining carbon dioxide due to the failure of their ventilatory muscle pump and not responding to prior non-invasive mask ventilation. Since intubation with subsequent (prolonged) invasive mechanical ventilation is associated with considerable side effects this new strategy has the potential to improve overall clinical outcome in this selected patient group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECLA-group | Experimental | Treatment with a pump driven, venovenous extracorporeal lung assist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vv-ECCO2R (Novalung GmbH, Germany) | Device | Treatment with the extracorporeal lung assist (ECLA) The ECLA is a pump driven (centrifugal pump) venovenous circuit, which removes carbon dioxide from the patients blood by means of a membrane through which the patients blood runs on the one side of the membrane and sweep gas on the other side removing the patient´s carbon dioxide. Blood flow range from 0.5 to 4.5 l/min and sweep gas flow between 1 and 10 l/min. At blood flows of 2 l/min and higher the device also oxygenates the patients blood. The diameter and length of cannulas and the sites of venous insertions are left to the decision of the treating physician. Cannulas are inserted in seldinger technique under sterile conditions. Function and patency of the extracorporeal circuit requires mild therapeutic anticoagulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Need for Intubation for Invasive Mechanical Ventilation | The number of patients in the ECLA-group who had to be intubated and mechanically ventilated under the given criteria for inclusion and exclusion is collected. Since every patient in the matched control group was intubated, the comparison of the groups shows whether the use of a pump-driven venovenous extracorporeal lung assist can reduce the frequency of intubation and mechanical ventilation. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Non-invasive Ventilation | The duration of non-invasive ventilation up to day 90 is used to evaluate the respiratory outcomes of ECLA versus invasive mechanical ventilation. | 90 days |
| Complication Rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Kluge, MD | Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Intensive Care Medicine, University Medical-Center Hamburg-Eppendorf (plus 10 further centres in Germany, Austria and the Netherlands) | Hamburg | 22399 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22836139 | Background | Kluge S, Braune SA, Engel M, Nierhaus A, Frings D, Ebelt H, Uhrig A, Metschke M, Wegscheider K, Suttorp N, Rousseau S. Avoiding invasive mechanical ventilation by extracorporeal carbon dioxide removal in patients failing noninvasive ventilation. Intensive Care Med. 2012 Oct;38(10):1632-9. doi: 10.1007/s00134-012-2649-2. Epub 2012 Jul 27. | |
| 27456703 |
| Label | URL |
|---|---|
| Department of principal investigator | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ECLA-group | Treatment with a pump driven, venovenous extracorporeal lung assist vv-ECCO2R (Novalung GmbH, Germany): Treatment with the extracorporeal lung assist (ECLA) The ECLA is a pump driven (centrifugal pump) venovenous circuit, which removes carbon dioxide from the patients blood by means of a membrane through which the patients blood runs on the one side of the membrane and sweep gas on the other side removing the patient´s carbon dioxide. Blood flow range from 0.5 to 4.5 l/min and sweep gas flow between 1 and 10 l/min. At blood flows of 2 l/min and higher the device also oxygenates the patients blood. The diameter and length of cannulas and the sites of venous insertions are left to the decision of the treating physician. Cannulas are inserted in seldinger technique under sterile conditions. Function and patency of the extracorporeal circuit requires mild therapeutic anticoagulation. |
| FG001 | Control Group | The historical controls were patients with acute hypercapnic respiratory failure refractory to NIV who were treated with IMV. The matching criteria were main diagnosis, age, SAPS-II score and pH. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ECLA Group | Treatment with a pump driven, venovenous extracorporeal lung assist vv-ECCO2R (Novalung GmbH, Germany): Treatment with the extracorporeal lung assist (ECLA) The ECLA is a pump driven (centrifugal pump) venovenous circuit, which removes carbon dioxide from the patients blood by means of a membrane through which the patients blood runs on the one side of the membrane and sweep gas on the other side removing the patient´s carbon dioxide. Blood flow range from 0.5 to 4.5 l/min and sweep gas flow between 1 and 10 l/min. At blood flows of 2 l/min and higher the device also oxygenates the patients blood. The diameter and length of cannulas and the sites of venous insertions are left to the decision of the treating physician. Cannulas are inserted in seldinger technique under sterile conditions. Function and patency of the extracorporeal circuit requires mild therapeutic anticoagulation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Need for Intubation for Invasive Mechanical Ventilation | The number of patients in the ECLA-group who had to be intubated and mechanically ventilated under the given criteria for inclusion and exclusion is collected. Since every patient in the matched control group was intubated, the comparison of the groups shows whether the use of a pump-driven venovenous extracorporeal lung assist can reduce the frequency of intubation and mechanical ventilation. | Posted | Count of Participants | Participants | 21 days |
|
90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ECLA-group | Treatment with a pump driven, venovenous extracorporeal lung assist vv-ECCO2R (Novalung GmbH, Germany): Treatment with the extracorporeal lung assist (ECLA) The ECLA is a pump driven (centrifugal pump) venovenous circuit, which removes carbon dioxide from the patients blood by means of a membrane through which the patients blood runs on the one side of the membrane and sweep gas on the other side removing the patient´s carbon dioxide. Blood flow range from 0.5 to 4.5 l/min and sweep gas flow between 1 and 10 l/min. At blood flows of 2 l/min and higher the device also oxygenates the patients blood. The diameter and length of cannulas and the sites of venous insertions are left to the decision of the treating physician. Cannulas are inserted in seldinger technique under sterile conditions. Function and patency of the extracorporeal circuit requires mild therapeutic anticoagulation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bleeding | Blood and lymphatic system disorders | Systematic Assessment | major bleeding |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| minor bleeding | Blood and lymphatic system disorders | Systematic Assessment |
An important methodological limitation of our study is that the criteria used to define "NIV failure" and "indication for intubation" in the ECCO 2R group left a degree of subjective clinical judgement to the attending intensivist.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Stefan Kluge | University Medical Center Hamburg-Eppendorf, Germany | +49-40-7410 | 57011 | skluge@uke.de |
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| ID | Term |
|---|---|
| D006935 | Hypercapnia |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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|
Major complication associated with the pump driven extracorporeal lung assist device or with non-invasive or invasive mechanical ventilation or any associated treatments during the observational period
| 90 days |
| Length of Invasive Mechanical Ventilation if Intubated | Describes the length of invasive mechanical ventilation in days, in case intubation and mechanical ventilation became necessary | 90 days |
| Length of Stay in ICU | Describes the length of stay in ICU | 90 days |
| Mortality | Comparison of 90-day mortality between the study arms. Seven patients died in each of the two arms after 90 days, so the stated values are correct. | 90 days |
| Braune S, Sieweke A, Brettner F, Staudinger T, Joannidis M, Verbrugge S, Frings D, Nierhaus A, Wegscheider K, Kluge S. The feasibility and safety of extracorporeal carbon dioxide removal to avoid intubation in patients with COPD unresponsive to noninvasive ventilation for acute hypercapnic respiratory failure (ECLAIR study): multicentre case-control study. Intensive Care Med. 2016 Sep;42(9):1437-44. doi: 10.1007/s00134-016-4452-y. Epub 2016 Jul 25. |
| BG001 | Control Group | Control patients were identified and their data retrospectively collected from a large patient database at the principal study centre. The control patients had also been admitted to Intensive Care Unit with hypercapnic ventilatory failure and subsequently failed non-invasive ventilation (NIV) treatment followed by intubation and invasive mechanical ventilation. Matching criteria for the historical controls were acute diagnosis leading to hypercapnic respiratory failure, age (±10), SAPS-II score (±6) on ICU admission and pH (±0.06) at the time of NIV failure. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group | The historical controls were patients with acute hypercapnic respiratory failure refractory to NIV who were treated with IMV. The matching criteria were main diagnosis, age, SAPS-II score and pH. |
|
|
| Secondary | Length of Non-invasive Ventilation | The duration of non-invasive ventilation up to day 90 is used to evaluate the respiratory outcomes of ECLA versus invasive mechanical ventilation. | As the control group receives 100% invasive mechanical ventilation by definition, this group is not analysed. | Posted | Mean | Full Range | days | 90 days |
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|
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| Secondary | Complication Rates | Major complication associated with the pump driven extracorporeal lung assist device or with non-invasive or invasive mechanical ventilation or any associated treatments during the observational period | Posted | Count of Participants | Participants | 90 days |
|
|
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| Secondary | Length of Invasive Mechanical Ventilation if Intubated | Describes the length of invasive mechanical ventilation in days, in case intubation and mechanical ventilation became necessary | Posted | Mean | Full Range | days | 90 days |
|
|
|
| Secondary | Length of Stay in ICU | Describes the length of stay in ICU | Posted | Mean | Full Range | days | 90 days |
|
|
|
| Secondary | Mortality | Comparison of 90-day mortality between the study arms. Seven patients died in each of the two arms after 90 days, so the stated values are correct. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| 7 |
| 25 |
| 11 |
| 25 |
| 4 |
| 25 |
| EG001 | Control Group | The historical controls were patients with acute hypercapnic respiratory failure refractory to NIV who were treated with IMV. The matching criteria were main diagnosis, age, SAPS-II score and pH. | 7 | 25 | 2 | 25 | 8 | 25 |
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| D012140 | Respiratory Tract Diseases |