Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400797
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-05-02
Brief Title:
Estimation of Outcome and Quality of Life in ECMO Patients
Sponsor:
Heinrich-Heine University Duesseldorf
Organization:
Heinrich-Heine University Duesseldorf
Study Overview
Official Title:
ESTimation of Outcome by Health-Care PRoviders Compared With TruE Outcome in Patients Undergoing Veno-arteriaL and Veno-venous ExtracorporeaL MembrAne Oxygenation
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTRELLA
Brief Summary:
The availability as well as the use of extracorporeal membrane oxygenation ECMO systems for severe acute respiratory or cardiocirculatory failure is steadily increasing The decision to initiate ECMO therapy is predominantly made in emergency situations for which the focus is on acute survival The decisions if a patient will profit from ECMO therapy are mainly made from clinical experience and educated guess by the attending team However it is unknown how useful these clinical predictions are Therefore this observational study will compare estimated and real outcome of ECMO patients
Detailed Description:
The availability as well as the use of extracorporeal membrane oxygenation ECMO systems for severe acute respiratory veno-venous vv-ECMO or cardiocirculatory veno-arterial va-ECMO failure is steadily increasing Despite increasing experience of specialized centres mortality of ECMO patients remains high and only about 50 survive the initial hospital stay For those patients who do leave the hospital alive quality of life after this invasive therapy with long stays in the intensive care unit ICU is often limited and participation in social life can be difficult Quality of life and the life-impact after ECMO therapy is in contrast to hard endpoints such as mortality insufficiently studied and currently only scarce data exist from large prospective cohort studies Further predictive scores and associated risk factors for patient-centred outcomes are not available
The decision to initiate ECMO therapy is predominantly made in emergency situations for which the focus is on acute survival As such the long-term implications in terms of quality of life and life-impact of ECMO treatment enjoy only limited consideration at an early time point Further the existing scores for prediction in ECMO were developed for mortality and reliable data on long-term life-impact are scarce Therefore while these decisions are influenced by empirical factors like patient-age point-of-care laboratory parameters eg lactate or the neurological status of the patient the clinical experience and educated guess in terms of prognosis and potential treatment futility by the attending team remains a crucial factor This applies not only to ECMO initiation but also to decisions on continuation and termination This approach to decision-making may be problematic since it has been shown for other settings that clinicians tend to overestimate the success of an intervention Currently there are no data evaluating in how far this also applies to ECMO therapy and if indeed there is a mismatch between estimated and observed outcomes in ECMO patients Considering the crucial role of subjective prognosis estimates it becomes of major interest to quantify the potential mis-calibration between clinicians estimated and observed outcomes Further factors like Outcome uncertainties potential doubts regarding treatment utility vs futility and the immediate finality of these demanding decisions expose ICU health-care personnel to a relevant psychological burden As shown by Johnson-Coyle and colleagues both moral distress and burnout have a negative impact on job satisfaction Moral distress occurs when one believes to know what is ethically right but something or someone limits their ability to do the right thing Preliminary studies have shown a high incidence of moral distress in the care of patients with mechanical circulatory support systems with particularly pronounced stress among nursing personnel If these factors have significant impact on professional judgement is not clear in this context
In a small single centre pilot study we prospectively recruited 50 va-ECMO patients at the University Hospital Duesseldorf from March until November 2023 and investigated if ECMO care providers could predict in-hospital mortality in these patients For these 50 patients we obtained 135 completed questionnaires within 24 hours and 111 answered questionnaires at day 4 to7 after initiation of ECMO therapy from consultants residents and nursing personnel Out of 50 patients 21 patients 42 died during the initial hospital stay Overall sensitivity and specificity of estimates were 579 and 859 respectively at 24 hours after start of ECMO therapy precision 75 accuracy 741 F1 score 653 In a subgroup analysis consultants showed highest agreement of estimated and actual in hospital mortality whereas residents showed lowest agreement see table below At day 4 to 7 overall predictions had lower sensitivity accuracy precision and F1-score as compared to estimates on day 1 after ECMO initiation however specificity slightly increased sens 35 spec 915 acc 711 F1-score 467 precision 70 Highest values for sensitivity accuracy and F1-score were reached in subgroup of nursing personnel see table below Notably years of experience in critical care were higher in consultants and nursing personnel as compared to residents consultants 108 67 years versus residents 14 15 years versus nursing personnel 158 104 years
Based on the results of our pilot data we hypothesize that
1 Subjective prognosis estimates by health care providers underestimate low sensitivity actual mortality We expect that this will also account for reduced functionality and quality of life
2 Estimations will vary significantly between different groups of health care professionals and levels of experience in critical care as well as between different time points of assessment Specifically we expect that prediction accuracy will improve with higher years of experience in critical care and that predictions for mortality will be more accurate immediately after ECMO initiation as compared to later study time points This might be influenced by the fact that a substantial number of patients with poor prognosis will die within the first four days of ECMO therapy Hence estimation of outcome in the remaining patients is more difficult
3 Agreement between estimated and observed outcomes will differ significantly between centres with different levels of experience high-volume versus low-volume centres Expecting higher accuracy of outcome estimates in high-volume centres with higher experience as compared to low-volume centres
4 Additionally we expect that high levels of moral distress influence professional judgement leading to negative estimated prognosis and low precisions of estimations
Therefore we aim to conduct the ESTRELLA study as large nationwide multicentre prospective cohort study to dissect usability of clinical estimates for outcome prediction in ECMO patients and to identify suitable factors for prediction of poor functional health in these patients
The decision to initiate ECMO therapy is predominantly made in emergency situations for which the focus is on acute survival As such the long-term implications in terms of quality of life and life-impact of ECMO treatment enjoy only limited consideration at an early time point Further the existing scores for prediction in ECMO were developed for mortality and reliable data on long-term life-impact are scarce Therefore while these decisions are influenced by empirical factors like patient-age point-of-care laboratory parameters eg lactate or the neurological status of the patient the clinical experience and educated guess in terms of prognosis and potential treatment futility by the attending team remains a crucial factor This applies not only to ECMO initiation but also to decisions on continuation and termination This approach to decision-making may be problematic since it has been shown for other settings that clinicians tend to overestimate the success of an intervention Currently there are no data evaluating in how far this also applies to ECMO therapy and if indeed there is a mismatch between estimated and observed outcomes in ECMO patients Considering the crucial role of subjective prognosis estimates it becomes of major interest to quantify the potential mis-calibration between clinicians estimated and observed outcomes Further factors like Outcome uncertainties potential doubts regarding treatment utility vs futility and the immediate finality of these demanding decisions expose ICU health-care personnel to a relevant psychological burden As shown by Johnson-Coyle and colleagues both moral distress and burnout have a negative impact on job satisfaction Moral distress occurs when one believes to know what is ethically right but something or someone limits their ability to do the right thing Preliminary studies have shown a high incidence of moral distress in the care of patients with mechanical circulatory support systems with particularly pronounced stress among nursing personnel If these factors have significant impact on professional judgement is not clear in this context
In a small single centre pilot study we prospectively recruited 50 va-ECMO patients at the University Hospital Duesseldorf from March until November 2023 and investigated if ECMO care providers could predict in-hospital mortality in these patients For these 50 patients we obtained 135 completed questionnaires within 24 hours and 111 answered questionnaires at day 4 to7 after initiation of ECMO therapy from consultants residents and nursing personnel Out of 50 patients 21 patients 42 died during the initial hospital stay Overall sensitivity and specificity of estimates were 579 and 859 respectively at 24 hours after start of ECMO therapy precision 75 accuracy 741 F1 score 653 In a subgroup analysis consultants showed highest agreement of estimated and actual in hospital mortality whereas residents showed lowest agreement see table below At day 4 to 7 overall predictions had lower sensitivity accuracy precision and F1-score as compared to estimates on day 1 after ECMO initiation however specificity slightly increased sens 35 spec 915 acc 711 F1-score 467 precision 70 Highest values for sensitivity accuracy and F1-score were reached in subgroup of nursing personnel see table below Notably years of experience in critical care were higher in consultants and nursing personnel as compared to residents consultants 108 67 years versus residents 14 15 years versus nursing personnel 158 104 years
Based on the results of our pilot data we hypothesize that
1 Subjective prognosis estimates by health care providers underestimate low sensitivity actual mortality We expect that this will also account for reduced functionality and quality of life
2 Estimations will vary significantly between different groups of health care professionals and levels of experience in critical care as well as between different time points of assessment Specifically we expect that prediction accuracy will improve with higher years of experience in critical care and that predictions for mortality will be more accurate immediately after ECMO initiation as compared to later study time points This might be influenced by the fact that a substantial number of patients with poor prognosis will die within the first four days of ECMO therapy Hence estimation of outcome in the remaining patients is more difficult
3 Agreement between estimated and observed outcomes will differ significantly between centres with different levels of experience high-volume versus low-volume centres Expecting higher accuracy of outcome estimates in high-volume centres with higher experience as compared to low-volume centres
4 Additionally we expect that high levels of moral distress influence professional judgement leading to negative estimated prognosis and low precisions of estimations
Therefore we aim to conduct the ESTRELLA study as large nationwide multicentre prospective cohort study to dissect usability of clinical estimates for outcome prediction in ECMO patients and to identify suitable factors for prediction of poor functional health in these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None