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临床试验/NCT06786819
NCT06786819招募中不适用

Estudo Randomizado de Cluster Escalonado Para Avaliar o Impacto de Uma Plataforma tecnológica Baseada no ERAS (Enhanced Recovery After Surgery) no Tempo de permanência após Cirurgia de revascularização miocárdica: Projeto Tempos Certos - REPLICCAR III

University of Sao Paulo General Hospital3 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2025年3月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
480
试验地点
3
主要终点
Lenght of Stay

研究概览

简要总结

Cardiovascular diseases continue to be the leading cause of death worldwide. Among them, coronary artery disease has the greatest impact, being characterized as one of the main causes of death in Brazil over the last decade. One of the well-established treatments is coronary artery bypass grafting, which is the most performed among cardiac surgeries and, in our scenario, is primarily funded by the Unified Health System (SUS). The information obtained from the Paulista Registry of Cardiovascular Surgeries (REPLICCAR), in partnership with FAPESP, has been important for implementing improvements in the landscape of cardiac surgeries in the state of São Paulo. Although outcomes in cardiac surgery have improved due to the structuring and organization of quality programs, this is still not a reality at the national level. In a situation where data collection and quality initiatives play a central role in continuous improvement, generating value becomes essential for the sustainability of cardiac surgery programs. In this sense, the concept of Enhanced Recovery After Surgery (ERAS) has gained increasing traction. This concept is based on multidisciplinary protocols and scientific evidence, which help prepare patients for rapid recovery, resulting in reduced complications, shorter hospital stays, and, primarily, lower hospital costs. On the other hand, the increase in surgical waiting lists has also led to a rise in home mortality due to cardiac causes. Thus, among the various challenges imposed by the current scenario, the investigators believe that preparing patients for rapid recovery after coronary artery bypass grafting presents an opportunity for the sustainability of the healthcare system. Therefore, the aim of this project is to evaluate the impact of a technology platform based on ERAS on the postoperative recovery time of patients undergoing coronary artery bypass grafting in reference centers in the state of São Paulo, Timely Project - REPLICCAR III.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults over 18 years old
  • Indication for primary isolated CABG (elective or urgent status)
  • Own a personal cell phone
  • Have internet access
  • Knowledgeable in using the device
  • Full understanding and agreement regarding the informed consent form (ICF)

排除标准

  • Indication for associated surgery
  • Glycosylated hemoglobin level greater than 8%
  • Creatinine clearance less than 30 mL/min
  • Pre-operative atrial fibrillation or use of pre-operative anticoagulation
  • Hemoglobin less than 12 g/dL
  • Users of illicit drugs
  • STS score greater than 4%
  • Physical or mental disabilities that prevent adherence to the protocol
  • Refusal by the patient or family member

研究组 & 干预措施

Standard care for CABG

No Intervention

Patients will be treated with CABG following the standard of care for each participant institution.

ERACS with Digital Platform

Experimental

Patient will be treated by the participant institution following a modified protocol based in the ERACS with the aid of a digital platform.

干预措施: ERACS with Digital Platform (Other)

结局指标

主要结局

Lenght of Stay

时间窗: up to 30 days after surgery

Compare the length of stay after coronary artery bypass grafting (CABG) with versus without the use of a technology platform based on ERAS.

次要结局

  • Percentage of Completeness of Protocol Steps(up to 01 week after surgery.)
  • Morbility and Mortality(up to 6 months after surgery)
  • Patient-reported outcomes (PROM)(up to 6 months after surgery)
  • Patient reported experience measure(PREM)(up to 6 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Asdrúbal Vilca Mejia

Study Principal Investigator, Head of Quality and Safety Surgical Unit at the InCor Heart Institute

University of Sao Paulo General Hospital

研究点 (3)

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