When the ECLS is stopped...
There are several reasons why ECLS might be stopped. They involve change in patient status, disease progression, resource limitations and adherence to local protocols, patient or family wishes or sometimes complications with the ECLS circuit and/or its components.
Collecting these data is essential for improving patient outcomes, guiding clinical practice, and refining protocols, ultimately leading to more efficient, safer and targeted treatment approaches.
Stop reasons are collected for each core table. Depending on the core table, additional concepts specific to this table are available. Stop reasons are collected using the .stop_reason_concept_id column of each respective table.
...without complications
When an ECLS run is stopped and none of the circuit components or the circuit itself were replaced, each corresponding database entry (run, circuit, components) should have the same .stop_reason_concept_id.
...with complications
Complications on a circuit or component level might lead to an exchange of the faulty component as well as other parts of the circuit. Each affected component should have the same .stop_reason_concept_id.
General stop reasons
If no complication occurs, you can choose one of the following stop reasons to end your run for your respective database entries (run, circuit, components).
| concept_id | concept_name | comment |
|---|---|---|
| 4149524 | Patient's condition improved | This concept should be used to end a run and its circuit and components. |
| 434489 | Dead | This concept should be used to end a run and its circuit and components. |
| 4154766 | Moribund | This concept should be used to end a run and its circuit and components. |
| 4337306 | Implantation of ventricular assist device | This concept should be used to end a run and its circuit and components. |
| 4272324 | Cardiopulmonary bypass operation | This concept should be used to end a run and its circuit and components. |
| 4137127 | Transplantation of heart | This concept should be used to end a run and its circuit and components. |
| 4337138 | Transplant of lung | This concept should be used to end a run and its circuit and components. |
| 4138959 | Heart-lung transplant with recipient cardiectomy-pneumonectomy | This concept should be used to end a run and its circuit and components. |
| 40483850 | Treatment changed | Indicating that the circuit or component was not necessary anymore. This concept should not be used as concept to end a run but only for the circuit and/or components. (e.g.: switch from a double-circuit configuration to a single-circuit configuration or removal of one venous cannula in a VV-A (to V-A) configuration because of improved pulmonary function) |
| 44790553 | Following protocol | If the center demands a change/stop of the run, circuit and/or component, use this concept. |
| 36717877 | End of product life-cycle. | This concept should not be used as concept to end a run but only for the circuit and/or components. |
Death
If the patient dies, a respective entry in the OMOP CDM death table is necessary. Sometimes, ECLS support is withdrawn for a Moribund patient, because death is expected. The major difference between Dead and Moribund regarding data capture is the timestamp of death_datetime.
The patient dies "on ECLS"
Dead: death.death_datetime = ecls_run.stop_datetime
The patient is decannulated and dies shortly afterwards
Moribund: death.death_datetime > ecls_run.stop_datetime
Complications
| concept_id | concept_name1 | comment |
|---|---|---|
| 36717814 | Acute obstruction to extracorporeal blood flow | |
| 36717815 | Increasing resistance to extracorporeal blood flow | |
| 36717816 | Air in extracorporeal life support circuit or component | |
| 36717817 | Hemorrhage of extracorporeal life support vascular access | |
| 36717818 | Misplacement of extracorporeal life support cannula | |
| 36717820 | Decreased efficiency of extracorporeal membrane lung | |
| 4018050 | Localized infection | Wound infection at cannula entry site. If a change of the cannula is necessary due to infection at the cannula entry site, stop the removed cannula using this concept. |
| 36717821 | Recirculation | If recirculation is responsible for the exchange of the circuit and/or component it is considered a complication. If recirculation is observed but no direct intervention on the circuit is necessary, it should still be collected as observation. |
| 36717819 | Accidental dislodgement of extracorporeal life support component | Accidental dislodgment refers to the unintended displacement or removal of a component from its intended position. |
| 740911 | Accidental dislodgement of extracorporeal life support blood pump | |
| 740912 | Accidental dislodgement of extracorporeal life support cannula | |
| 740913 | Accidental dislodgement of extracorporeal life support console | |
| 740914 | Accidental dislodgement of extracorporeal life support membrane lung | |
| 740915 | Accidental dislodgement of extracorporeal life support temperature regulation device | |
| 36717822 | Coagulopathy caused by extracorporeal life support circuit or component | Coagulopathy is responsible for the stop or exchange of the circuit or component. |
| 36717823 | Coagulopathy caused by extracorporeal life support blood pump | |
| 36717825 | Coagulopathy caused by extracorporeal life support cannula | |
| 36717824 | Coagulopathy caused by extracorporeal life support circuit | |
| 36717826 | Coagulopathy caused by extracorporeal membrane lung | |
| 36717827 | Hemolysis caused by extracorporeal life support circuit or component | |
| 36717828 | Hemolysis caused by extracorporeal life support blood pump | Hemolysis is responsible for the stop or exchange of the circuit or component. |
| 36717830 | Hemolysis caused by extracorporeal life support cannula | |
| 36717829 | Hemolysis caused by extracorporeal life support circuit | |
| 36717831 | Hemolysis caused by extracorporeal membrane lung | |
| 36717832 | Blood clot in extracorporeal life support circuit or component | A blood clot is responsible for the stop or exchange of the circuit or component. |
| 36717833 | Blood clot in extracorporeal life support blood pump | |
| 36717835 | Blood clot in extracorporeal life support cannula | |
| 36717834 | Blood clot in extracorporeal life support circuit | |
| 36717836 | Blood clot in extracorporeal membrane lung | |
| 36717837 | Extracorporeal life support device failure | Use the following concepts for any technical malfunction that is not a loss of the structural integrity of the component. |
| 36717839 | Extracorporeal life support blood pump failure | |
| 36717841 | Extracorporeal life support cannula failure | |
| 36717842 | Extracorporeal life support circuit failure | |
| 36717843 | Extracorporeal life support console failure | |
| 36717840 | Extracorporeal life support temperature regulation device failure | |
| 36717838 | Extracorporeal membrane lung failure | |
| 36717844 | Impaired structural integrity of extracorporeal life support circuit or component | In contrast to any technical malfunction, an impaired structural integrity usually means a physical break of the component. |
| 740918 | Impaired structural integrity of extracorporeal life support blood pump | |
| 740919 | Impaired structural integrity of extracorporeal life support cannula | |
| 740920 | Impaired structural integrity of extracorporeal life support membrane lung | |
| 36717845 | Rupture of extracorporeal life support circuit tubing | |
| 36717846 | Raceway rupture of extracorporeal life support circuit tubing | A raceway rupture can occur using traditional roller-pump setups. Typically, modern circuits use a centrifugal magnetic pump, whereas roller pumps are more frequent in neonatal ECLS. |
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Parent/high-level concepts are in bold. ↩