Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257745
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-25
Brief Title:
Audit of the Revised PACU Centric ERACS Program
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Evaluation of the Revised Enhanced Recovery After Cardiac Surgery Protocol A Prospective Audit
Status:
RECRUITING
Status Verified Date:
2024-01
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:
ERACS2
Brief Summary:
A previous audit S63843 found an association between improved compliance with these interventions and postoperative outcomes hospital length of stay LOS and presence of 1 postoperative complication The investigators found that every 10 increase in compliance was associated with an increased risk HR125 p00008 for early discharge In addition improved compliance was also associated with a reduction OR060 p00003 of postoperative complications Based on these findings improving compliance with current guidelines remains a hurdle that clinicians should overcome The investigators previous retrospective study was unable to identify the reason for non-compliance and the relation to postoperative outcomes Therefore a prospective audit is warranted to assess reach fidelity and dose of the different interventions
Detailed Description:
Trial Design
Prospective audit in patients undergoing cardiac surgery and planned for overnight stay within our post-anesthesia care unit PACU enhanced recovery after cardiac surgery ERACS program The medical records of all patients will be evaluated for the implementation of various interventions of our ERACS program primary objective For the secondary objective the investigators will assess the occurrence of postoperative complications and hospital LOS
For benchmarking third objective the investigators will compare the findings with the results of a previous audit S638434 Data in this retrospective audit was collected from the electronic patient registry KWS Klinisch Werk Station This included all interventions described in the ERACS guidelines In addition postoperative complications that occurred up to 7 days were also collected
Data management
Data will be obtained according to the strategy used in the previous audit S63843 by a research collaborator and an anesthesiologist using the medical records of the included patients Appropriate data will also be collected from the preoperative anesthesia evaluation sheets digitally stored in the hospital information system KWS Nexus health and from all intra- and postoperative anesthesia records up to 30 days after the index surgery
Statistics
The investigators aim for a convenience sample of 1-year recruitment from January 1st 2024 until December 31st 2024 and expect to include approximately 350 cardiac surgical patients in this ERACS audit
Patient characteristics will be tabulated as absolute numbers percentages mean and standard deviation Objective 1 95 confidence intervals will be reported for the mean or median percentage compliances well as for each of the interventions separately the proportion of patients who adhere to the intervention
Objective 2 Logistic regressions will be used to verify the relation between the percentage adherence and the presence of a complication for each complication separately and for the composite endpoint Odds ratios and 95 confidence intervals will be reported These analyses will also be performed for the adherence at each intervention separately fidelity and dose Spearman correlations and MWU tests will be used to explore relations between adherence percentage and each intervention separately and length of hospital stay Given the possible presence of in-hospital mortality a LOS value higher than the maximal observed value of the discharged patients will be given to patients who die in the hospital when applying these rank-based methods Further Cox regressions will be used to model the cause-specific hazard in presence of in-hospital mortality and hazard ratios with 95CI will be given A multivariable logistic regression will be used to verify if the relation between protocol adherence and postoperative complications is not confounded by patient eg EuroSCORE II and procedural eg type of surgery being valvular bypass or minimally invasive characteristics To verify the independent impact of protocol adherence on length of stay a multivariable Cox regression will be used
Objective 3 For benchmarking purposes the percentage adherence will be compared between current sample and the data of the retrospective study using a linear normal model correcting for potential differences in patient-mix patient and procedural characteristics between both periods Note however that differences are expected to be minimal since the same inclusion criteria were used and the accrual period covered a full year To compare the adherence to each intervention separately and to compare the complication rates a logistic regression will be used
A p-value of less than 005 will be considered statistically significant Given the large number of planned statistical tests a single significant p-value will be interpreted with caution
Prospective audit in patients undergoing cardiac surgery and planned for overnight stay within our post-anesthesia care unit PACU enhanced recovery after cardiac surgery ERACS program The medical records of all patients will be evaluated for the implementation of various interventions of our ERACS program primary objective For the secondary objective the investigators will assess the occurrence of postoperative complications and hospital LOS
For benchmarking third objective the investigators will compare the findings with the results of a previous audit S638434 Data in this retrospective audit was collected from the electronic patient registry KWS Klinisch Werk Station This included all interventions described in the ERACS guidelines In addition postoperative complications that occurred up to 7 days were also collected
Data management
Data will be obtained according to the strategy used in the previous audit S63843 by a research collaborator and an anesthesiologist using the medical records of the included patients Appropriate data will also be collected from the preoperative anesthesia evaluation sheets digitally stored in the hospital information system KWS Nexus health and from all intra- and postoperative anesthesia records up to 30 days after the index surgery
Statistics
The investigators aim for a convenience sample of 1-year recruitment from January 1st 2024 until December 31st 2024 and expect to include approximately 350 cardiac surgical patients in this ERACS audit
Patient characteristics will be tabulated as absolute numbers percentages mean and standard deviation Objective 1 95 confidence intervals will be reported for the mean or median percentage compliances well as for each of the interventions separately the proportion of patients who adhere to the intervention
Objective 2 Logistic regressions will be used to verify the relation between the percentage adherence and the presence of a complication for each complication separately and for the composite endpoint Odds ratios and 95 confidence intervals will be reported These analyses will also be performed for the adherence at each intervention separately fidelity and dose Spearman correlations and MWU tests will be used to explore relations between adherence percentage and each intervention separately and length of hospital stay Given the possible presence of in-hospital mortality a LOS value higher than the maximal observed value of the discharged patients will be given to patients who die in the hospital when applying these rank-based methods Further Cox regressions will be used to model the cause-specific hazard in presence of in-hospital mortality and hazard ratios with 95CI will be given A multivariable logistic regression will be used to verify if the relation between protocol adherence and postoperative complications is not confounded by patient eg EuroSCORE II and procedural eg type of surgery being valvular bypass or minimally invasive characteristics To verify the independent impact of protocol adherence on length of stay a multivariable Cox regression will be used
Objective 3 For benchmarking purposes the percentage adherence will be compared between current sample and the data of the retrospective study using a linear normal model correcting for potential differences in patient-mix patient and procedural characteristics between both periods Note however that differences are expected to be minimal since the same inclusion criteria were used and the accrual period covered a full year To compare the adherence to each intervention separately and to compare the complication rates a logistic regression will be used
A p-value of less than 005 will be considered statistically significant Given the large number of planned statistical tests a single significant p-value will be interpreted with caution
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