Audit of the Revised PACU Centric ERACS Program

NCT06257745 | Unknown

• 1 other identifier: s68333
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Enhanced Recovery After Surgery; Cardiac Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Hospital length of stay following the index surgery

  From date of surgery until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 30days.

• Occurrence of each postoperative complication during the first 7 days

  From date of surgery up to 7 postoperative days

• Composite endpoint of 1 or more postoperative complications

  From date of surgery up to 7 postoperative days

• Percentage of patients in whom each ERACS intervention was performed as intended (referred to as fidelity)

  From 6 week prior to surgery up to 1 month after surgery

• Percentage of patients in whom each the frequency of ERACS intervention was performed as planned (referred to as dose)

  From 6 week prior to surgery up to 1 month after surgery

Other Outcomes (1)

• Benchmarking purpose

  From 6 week prior to surgery up to 1 month after surgery

Study Arms (1)

ERACS group

Any patient admitted to our post-anesthesia care unit following cardiac surgery and planned for overnight stay.

Other: Compliance with ERACS guideline as described in the current ERACS guidelines from Engelman et al. 2019

Interventions

Compliance with ERACS guideline as described in the current ERACS guidelines from Engelman et al. 2019 OTHER

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

ERACS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

any patient undergoing cardiac surgery in our hospital and requiring admittance to a high-depency unit for overnight stay.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

Related 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.

  PMID: 31054241 BACKGROUND

• 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. 2024 Apr;167(4):1363-1371.e2. doi: 10.1016/j.jtcvs.2022.07.010. Epub 2022 Jul 19.

  PMID: 35989120 BACKGROUND

• 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.

  PMID: 27321791 BACKGROUND

• 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.

  PMID: 35501840 BACKGROUND

MeSH Terms

Interventions

Compliance

Intervention Hierarchy (Ancestors)

Elasticity; Mechanical Phenomena; Physical Phenomena

Study Officials

• Danny Feike Hoogma, MD, PhD

  Anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danny Feike Hoogma, MD, PhD

CONTACT

003216344270; danny.hoogma@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 14, 2024
• Study Start: January 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 14, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available following the publication of the current audit in a peer reviewed journal
• Access Criteria: Detailes request for IPD needs to be addressed to the PI.

Locations

BE (1)