Actively Recruiting
Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery
Led by University of Sao Paulo General Hospital · Updated on 2024-12-03
128
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (>18 years old)
- Undergoing isolated coronary artery bypass grafting (CABG) with elective or urgent status
- Signed informed consent form (ICF)
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hc Da Fmusp Instituto Do Coracao Incor Sao Paulo
São Paulo, São Paulo, Brazil, 5403000
Actively Recruiting
Research Team
O
Omar A V Mejia, md, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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