Actively Recruiting
Study to Evaluate the Impact of the Recovery Pathway on Postoperative Length 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a rapid recovery protocol for patients undergoing coronary artery bypass grafting (CABG) in a hospital serving the Brazilian Unified Health System (SUS). This prospective, randomized trial compares outcomes between patients receiving care under the rapid recovery protocol and those following standard institutional care. The study aims to assess differences in postoperative hospital stay, morbidity, mortality, patient satisfaction, costs, healthcare team learning, protocol adherence, and patient safety culture. The study involves two groups: one receiving usual care and the other managed with the Tempos Certos protocol designed to enhance recovery through a multidisciplinary approach using scientifically recommended interventions. The trial monitors care from hospital admission through the postoperative period, including readmissions within 30 days after discharge. The primary goal is to compare hospital stay length from ICU admission until discharge. Participants will undergo assessments including morbidity and mortality within 30 days post-surgery, quality of life surveys before surgery and after discharge, anxiety and depression questionnaires, and patient experience evaluations. Costs will be analyzed using micro-costing methods. The healthcare teams' learning progress and adherence to the protocol, as well as changes in patient safety culture, will be measured. The total hospital stay is expected to average 14 days, with follow-ups extending to 30 days after discharge.
CONDITIONS
Brief 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 (over 18 years old)
- Undergoing isolated coronary artery bypass grafting (CABG) with elective or urgent status
- Signed informed consent form
You will not qualify if you...
- Emergency patients
- Severe ventricular dysfunction with ejection fraction less than 30%
- Renal impairment with creatinine clearance less than 30 mL/min
- Atrial fibrillation or need for oral anticoagulation
- Moderate-to-severe anemia with hematocrit less than 32%
- STS risk score greater than 4%
- Patient and/or family disagreement with the protocol
- Failure to sign the informed consent form
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 14 days from admission to hospital discharge
Participants undergo coronary artery bypass surgery and receive either the usual care or the interventional Tempos Certos protocol to improve recovery.
Hospital stay including admission to intensive care unit and postoperative care
Duration - Up to 30 days after hospital discharge
Participants are monitored for complications, quality of life, anxiety, depression, and patient experience up to 30 days after hospital discharge.
Assessments before surgery, at hospital discharge, and between 3 and 30 days after discharge
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
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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