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临床试验/NCT06257745
NCT06257745已完成不适用

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

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 487 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
487
试验地点
1
主要终点
Overall percentage of compliance with the 24 interventions of the ERACS guidelines

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

ERACS group

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

干预措施: Compliance with ERACS guideline as described in the current ERACS guidelines from Engelman et al. 2019 (Other)

结局指标

主要结局

Overall percentage of compliance with the 24 interventions of the ERACS guidelines

时间窗: From 6 week prior to surgery up to 1 month after surgery

Performed interventions as described in the ERACS guidelines and adapted to local standards

次要结局

  • Composite endpoint of 1 or more postoperative complications(From date of surgery up to 7 postoperative days)
  • 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.)
  • 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)
  • Occurrence of each postoperative complication during the first 7 days(From date of surgery up to 7 postoperative days)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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