Идёт набор NCT06713096

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

Без фазы С лечением Enhanced Recovery After Surgery Quality Improvement

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Tempos Certos protocol.
Кому может быть актуально: Состояния в реестре: Enhanced Recovery After Surgery, Quality Improvement. Базовые параметры: Без ограничений · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бразилия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Поведенческое 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.

Первичные конечные точки

Postoperative hospital stay [Срок оценки: From admission to the intensive care unit until hospital discharge (an average of 14 days of leght of hospital stay)]

Вторичные конечные точки (5)

Number of participants with cardiac reoperation, deep sternal wound infection/mediastinitis, stroke, prolonged ventilation, renal failure, or death within 30 days after surgery (morbimortality) [Срок оценки: Hospital stay to 30 days after hospital discharge (an average of 14 days of leght of hospital stay)]
Patient-reported Patient-reported quality of life (SF-36) [Срок оценки: Before surgery and 30 days after hospital discharge (an average of 14 days of leght of hospital stay)]
Patient-reported Anxiety and depression (HADS) [Срок оценки: Intervention group: Before surgery, at hospital discharge, and 30 days after hospital discharge. Control group: Before surgery and 30 days after hospital discharge (an average of 14 days of leght of hospital stay)]
Patient experience (HCAHPS) [Срок оценки: Between 3 and 30 days after hospital discharge (an average of 14 days of leght of hospital stay).]
Incremental Costs Assessed Using Micro-Costing Analysis [Срок оценки: From hospital admission through the postoperative period, including readmissions up to 30 days after discharge.]

Критерии участия

Критерии включения

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