Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery

Recruiting now · Not applicable

Conditions studied: Enhanced Recovery After Surgery, Quality Improvement

In brief

This randomized and prospective trial aims to evaluate the implementation of a rapid recovery protocol for coronary artery bypass grafting (CABG) in a hospital serving patients from the Brazilian Unified Health System (Sistema Único de Saúde - SUS). The study will compare outcomes between two groups: patients receiving care under the rapid recovery protocol and those following the standard institutional care. Primary Objective: Compare postoperative hospital stay between the rapid recovery group and the usual care group. Secondary Objectives: Assess morbidity and mortality between both groups. Evaluate patient satisfaction using validated tools. Analyze incremental costs associated with both approaches. Assess healthcare teams' learning progression regarding the protocol (Kirkpatrick method). Evaluate adherence to rapid recovery protocol metrics by healthcare teams. Measure changes in patient safety culture among healthcare professionals. Hypothesis: The null hypothesis assumes no difference in hospital stay between the two groups. The alternative hypothesis suggests that the rapid recovery protocol will reduce hospital stay compared to the standard care. Previous findings from Mejia et al. (2022) indicated a 40% reduction in postoperative hospital stay (from 13 to 7.8 days) for cardiac surgery patients under a rapid recovery protocol at the Heart Institute (InCor HCFMUSP). This trial will provide critical insights into the applicability of enhanced recovery after surgery (ERAS) principles in cardiac surgery within the context of public healthcare, aiming to improve outcomes and optimize resource use.

Key facts

Study ID

NCT06713096

Run by

University of Sao Paulo General Hospital

People needed

128

Starts

2021-11-25

Expected to finish

2025-12-01

Last updated by the study team

2024-12-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (>18 years old)
• Undergoing isolated coronary artery bypass grafting (CABG) with elective or urgent status
• Signed informed consent form (ICF)

You may not qualify if…

• Emergency patients
• Severe ventricular dysfunction (ejection fraction <30%)
• Renal impairment (creatinine clearance <30 mL/min)
• Atrial fibrillation or need for oral anticoagulation
• Moderate-to-severe anemia (hematocrit <32%)
• STS risk score >4%
• Patient and/or family disagreement with the protocol
• Failure to sign the informed consent form

Where it is running

• Hc Da Fmusp Instituto Do Coracao Incor Sao Paulo — São Paulo, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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