Audit of the Revised PACU Centric ERACS Program

Cardiac Surgical Procedures Clinical Trial

— ERACS2  

Official title:

Evaluation of the Revised Enhanced Recovery After Cardiac Surgery Protocol. A Prospective Audit.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257745
• Other study ID #: s68333
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Danny Feike Hoogma, MD, PhD
• Phone: 003216344270
• Email: danny.hoogma[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 (HR=1.25, p=0.0008) for early discharge. In addition, improved compliance was also associated with a reduction (OR=0.60, p=0.0003) 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.

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 (S63843).(4) 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 95%CI) 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 (e.g. EuroSCORE II) and procedural (e.g. 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 rate(s) a logistic regression will be used.

A p-value of less than 0.05 will be considered statistically significant. Given the large number of planned statistical tests, a single significant p-value will be interpreted with caution.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Included in our post anesthesia care unit centric ERACS program during 2024

Exclusion Criteria:

• Patients transferred to the PACU but awaiting planned admission to the intensive care unit following cardiac surgery

Related Conditions & MeSH terms

• Cardiac Surgical Procedures
• Enhanced Recovery After Surgery

Intervention

Other:
• Compliance with ERACS guideline as described in the current ERACS guidelines from Engelman et al. 2019
Compliance with the interventions as proposed in the ERACS guidelines and described in our previous publication (https://doi.org/10.1016/j.jtcvs.2022.07.010

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153. — View Citation

Fleming IO, Garratt C, Guha R, Desai J, Chaubey S, Wang Y, Leonard S, Kunst G. Aggregation of Marginal Gains in Cardiac Surgery: Feasibility of a Perioperative Care Bundle for Enhanced Recovery in Cardiac Surgical Patients. J Cardiothorac Vasc Anesth. 2016 Jun;30(3):665-70. doi: 10.1053/j.jvca.2016.01.017. Epub 2016 Jan 16. — View Citation

Hoogma DF, Croonen R, Al Tmimi L, Tournoy J, Verbrugghe P, Fieuws S, Rex S. Association between improved compliance with enhanced recovery after cardiac surgery guidelines and postoperative outcomes: A retrospective study. J Thorac Cardiovasc Surg. 2022 Jul 19:S0022-5223(22)00794-2. doi: 10.1016/j.jtcvs.2022.07.010. Online ahead of print. — View Citation

Van Grootven B, Jeuris A, Jonckers M, Devriendt E, Dierckx de Casterle B, Dubois C, Fagard K, Herregods MC, Hornikx M, Meuris B, Rex S, Tournoy J, Milisen K, Flamaing J, Deschodt M. How to implement geriatric co-management in your hospital? Insights from the G-COACH feasibility study. BMC Geriatr. 2022 May 2;22(1):386. doi: 10.1186/s12877-022-03051-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Benchmarking purpose	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 rate(s) a logistic regression will be used.	From 6 week prior to surgery up to 1 month after surgery
Primary	Overall percentage of compliance with the 24 interventions of the ERACS guidelines	Performed interventions as described in the ERACS guidelines and adapted to local standards	From 6 week prior to surgery up to 1 month after surgery
Secondary	Hospital length of stay following the index surgery	Number of nights in the hospital	From date of surgery until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 30days.
Secondary	Occurrence of each postoperative complication during the first 7 days	Complications as described in our previous publication (https://doi.org/10.1016/j.jtcvs.2022.07.010)	From date of surgery up to 7 postoperative days
Secondary	Composite endpoint of 1 or more postoperative complications	Complications as described in our previous publication (https://doi.org/10.1016/j.jtcvs.2022.07.010)	From date of surgery up to 7 postoperative days
Secondary	Percentage of patients in whom each ERACS intervention was performed as intended (referred to as fidelity)	Interventions as described in the ERACS guidelines	From 6 week prior to surgery up to 1 month after surgery
Secondary	Percentage of patients in whom each the frequency of ERACS intervention was performed as planned (referred to as dose)	Number of interventions as described in the ERACS guidelines	From 6 week prior to surgery up to 1 month after surgery