Cardiac Arrest, Extracorporeal Membrane Oxygenation, Hypoxia-Ischemia, Brain
Conditions
Brief summary
In ECPR, where CPR times often range from 30 to 120 minutes, only patients with good circulation during CPR survive, while non-survivors commonly suffer from anoxic brain injury. The selection process during CPR is challenging causing a general survival rate of just 2 out of 10, and the urgent need for better selection criteria has been emphasized. It it crucial to keep cardiac arrest times as short as possible, pre primed-ECMO can facilitate this. The ECMO treatment and the long CPR times of ECPR can also affect the measurements of the neurologic prognostication guidelines after cardiac arrest, making its validity uncertain in this specific cohort. Further, the long-term neuropsychological follow-up is limited to a few patients, making it uncertain if ECPR gives the survivors good long-term life satisfaction or just a prolonged life. Our overall aim is to optimize and improve the care pathway for ECPR patients by refining patient selection, assessing pre-primed ECMO, validating neurological prognostication guidelines, and understanding long-term outcomes and challenges faced by survivors. Specific Aim 1: Evaluating predictors for good neurological outcomes in ECPR and to develop and validate (internally and externally) an evidence-based selection tool for ECPR. Specific aim 2: To assess the sterility and function of pre-primed ECMO. Specific aim 3: To evaluate the applicability of current guidelines for neurological prognostication after cardiac arrest in ECPR patients, and to assess the predictive value of individual and combined neurological tests in this specific patient population. Specific aim 4: To determine the long-term neuropsychological outcomes, identify the problems survivors experience in daily life, and assess life satisfaction - by comprehensive follow-up visits with validated questionnaires and neuropsychology testing up to 12 years after the ECMO-treated cardiac arrest.
Detailed description
Specific aim 1: The aim is to develop an ECPR prognostication tool and validate its performance. In development, possible predictors for good neurological outcomes are prospectively gathered. The predictive ability of the predictors is tested in univariate and multivariable analysis, with the aim of improving patient selection for ECPR. Patients from the Gothenburg ECPR cohort are included in the development study. External validation with the ECMO patients from the Prague OHCA trial, following guidelines for validation studies, will follow, as well as external validation with further patients from Gothenburg. Specific aim 2: Cardiohelp ECMO circuits are set up dry, followed by wet-priming and used in the ECMO treatments of the centre. The circuits are cultured at ECMO-initiation and the incidence of positive cultures is assessed. The effect of the pre-primed time on ECMO function is also assessed. Specific aim 3: The predictive ability of the current guideline for neurological prognostication of comatose patients in the ICU after cardiac arrest, from the European Resuscitation Council, is assessed in the ECPR cohort of Gothenburg. The diagnostic performance of individual predictors as well as the total accuracy of the prediction will be assessed. Specific aim 4: A Long-term (1-12 years) follow-up of the ECPR patients will be performed, to determine the long-term neuropsychological outcomes. 4 A: Life satisfaction after ECPR will be assessed along with anxiety, depression, fatigue, cognitive function, and physical activity. The impact of these factors on life satisfaction will also be evaluated. QUALY will be calculated. 4 B: Long-term neurocognitive function in ECPR patients will be assessed through comprehensive neuropsychological testing, using conventional CPR patients from the TTM2 trial as a control group. The general ECMO population from 2004 of the center is included as a control group and positive cultures during their ECMO runs are documented.
Interventions
No intervention, but ECPR patients will be compared to ECMO-patients that have not had cardiac arrest
Sponsors
Study design
Eligibility
Inclusion criteria
* ECMO-treated patients.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin scale (MRs) | 1 year | Assessmenty of cognitive function. 0-6, where 0 is best. |
| Performance of ECMO oxygenator function | 0-60 days | Oxygenator resistance, and the needed FiO2 and sweep gas flow will be assessed |
| Positive cultures of pre-primed ECMO circuits | 0-90 days | ECMO circuits is pre-primed and cultures taken at the start of ECMO treatment |
| Predictive ability of ERC neuro prognostication guidelines on ECPR patients | 1 year | Diagnostic performance and ROC analysis of individual and total ERC predictors on outcome in ECPR |
| Life Satisfaction | 1-12 years | Visual Analog Scale 1-10. 10 is better. |
| Euro Qualy - 5 dimension (EQ-5D-5L) VAS | 3 months to 12 years | Self-perceived health status. 0-100, where higher is better. |
| Neurocognitive function | 3 months to 12 years after the ECPR-treatment | Z-scores of verbal and visual function, episodic and visuospatial memory , processing speed and executive functions. 0 represents standardized population norm and ± 1 represent one standard deviation from that. |
| Positive blood Cultures | 1 month | Infection rates in ECMO-patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MoCA | 3 months to 12 years after the ECPR treatment | Assess cognitive function, higher is better. 0-30 where higher is better |
| Hospital Anxiety and Depression Scale (HADS) | 3 months to 12 years | Two sub scales 0-21 which assess anxiety and depression, higer is worse |
| Mental Fatigue Scale | 3 months to 12 years | Assess fatigue 0-42 points. Higher is worse |
| modified Rankin Scale | 3 months to 12 years | physical function from 0-6 where 0 is best |
| Actual physical activity | 3 months to 12 years | Days per seven days with more than 30 minutes of physical activity |
Countries
Sweden
Contacts
The Sahlgrenska Academy ar Sahlgrenska University Hospital, Gorhenburg, Sweden