About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ECMO-treated patients.
Disqualifiers
None
Trial population
ECPR Group: Patients who is put on ECMO during cardiac arrest. ECMO Group: Patients who is put on ECMO with some ongoing circulaiton
Trial design
Cohort
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention, but ECPR patients will be compared to ECMO-patients that have not had cardiac arrest
Treatment groups
Trial outcomes
Primary outcomes
Modified Rankin scale (MRs)
Assessmenty of cognitive function. 0-6, where 0 is best.
Performance of ECMO oxygenator function
Oxygenator resistance, and the needed FiO2 and sweep gas flow will be assessed
Positive cultures of pre-primed ECMO circuits
ECMO circuits is pre-primed and cultures taken at the start of ECMO treatment
Predictive ability of ERC neuro prognostication guidelines on ECPR patients
Diagnostic performance and ROC analysis of individual and total ERC predictors on outcome in ECPR
Secondary outcomes
MoCA
Assess cognitive function, higher is better. 0-30 where higher is better
Hospital Anxiety and Depression Scale (HADS)
Two sub scales 0-21 which assess anxiety and depression, higer is worse
Mental Fatigue Scale
Assess fatigue 0-42 points. Higher is worse
modified Rankin Scale
physical function from 0-6 where 0 is best
Other outcomes
Cost
The in hospital cost of the treatment for the patients, in Swedish kronor.
Short Form -36 (SF-36)
Quality of life. 8 scaled scores from 0-100, where 100 is best.
Trailmaking test
Assessmenty of cognitive function. Shorter time is better.
New York heart association class (NYHA class)
Assessment of physical function.1-4, where 1 is best
Sponsors and contacts
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