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

University of Sao Paulo General Hospital

Status: Enrolling

Conditions: Quality Improvement; Enhanced Recovery After Surgery

Treatments: Behavioral: Tempos Certos protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06713096

50781921600000068 (Registry Identifier)

528421059

Details and patient eligibility

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.

Enrollment: 128 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups

Usual care

No Intervention group

Interventional care

Active Comparator group

Treatment:

Behavioral: Tempos Certos protocol