Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery
NCT ID: NCT06713096
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
128 participants
INTERVENTIONAL
2021-11-25
2025-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Usual care
No interventions assigned to this group
Interventional care
Tempos Certos protocol
Improve the enhanced recovery by using the Tempos Certos Protocol by the multiprofissional team , using interventions known by science and recommended by scientists.
Interventions
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Tempos Certos protocol
Improve the enhanced recovery by using the Tempos Certos Protocol by the multiprofissional team , using interventions known by science and recommended by scientists.
Eligibility Criteria
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Inclusion Criteria
* Undergoing isolated coronary artery bypass grafting (CABG) with elective or urgent status
* Signed informed consent form (ICF)
Exclusion Criteria
* 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
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Gabrielle B Borgomoni, bsc, PhD student
Role: PRINCIPAL_INVESTIGATOR
Instituto do coração
Locations
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Hc Da Fmusp Instituto Do Coracao Incor Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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50781921600000068
Identifier Type: REGISTRY
Identifier Source: secondary_id
528421059
Identifier Type: -
Identifier Source: org_study_id