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临床试验/NCT06815510
NCT06815510已完成不适用

Multicentral Observational Prospective Study on Prevalence of Post Anesthesia Care Unit Complications and Associated Factors

Ángel Becerra-Bolaños, MD PhD8 个研究点 分布在 2 个国家目标入组 1,778 人开始时间: 2025年2月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,778
试验地点
8
主要终点
Rate of patients with postoperative complications in the postanesthesia care unit

研究概览

简要总结

The post-anesthesia care unit (PACU) is a crucial component of the surgical process, providing patients with vital support and monitoring as they recover from anesthesia. Despite advancements in perioperative anesthesia, PACU complications are still common. PACU organization and setup in low-income country like Ethiopia is poor. Previous research's done in some neighbor African countries presumed to have comparable to sociodemographic and economical profile shows varied degree of incidence and prevalence of PACU complication and associated factors. The main objective of this study is to determine the prevalence of PACU complications and its associated factors.

An institutional based prospective cohort study will be conducted in the PACUs of the three selected tertiary care hospitals in Ethiopia from Februery 15, 2025 to June 30, 2025. These data will be compared with those obtained in a tertiary hospital in Spain.

详细描述

Studying the prevalence and associated factors of PACU complications will be of great academic importance, serving as a valuable reference and resource for further research. It will also help identify risk factors attributable to PACU complications, providing critical insights for hospital administrators and policymakers in making informed decisions about resource allocation and system design to minimize these complications. Understanding the prevalence and potential risk factors of PACU complications is essential for optimizing patient care and improving outcomes. Identified risk factors for postoperative complications in the PACU include female sex, longer duration of anesthesia, and the occurrence of intraoperative complications. This study aims to explore the prevalence of complications in the PACU and identify potential contributing factors, providing valuable insights for healthcare providers and policymakers seeking to improve PACU care. the potential significance and implications of the study findings, includes; Improving the understanding of PACU complications and the associated risk factors, informing the development of targeted prevention and management strategies, enhancing patient safety and quality of care in the perioperative setting and providing a basis for future research and evidence-based clinical guidelines. The study will involve surgical patients admitted to the Post-Anesthesia Care Units (PACUs) of four hospitals: Hiwot Fana Comprehensive Specialized Hospital, Ayder Comprehensive Specialized Hospital, Jimma University Medical Center (Ethiopia) and Hospital Universitario de Gran Canaria Doctor Negrín (Spain). The research will take place from February 15, 2025, to June 30, 2025. Multicenter, prospective, observational cohort study will be conducted reviewing patients admitted to the PACU. Analyzing complications in all patients admitted to the PACUs at the four selected hospitals following surgery under general, regional, or monitored anesthesia will be included in the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •All patients admitted to the Post-Anesthesia Care Units (PACUs) following surgery under general, regional, or monitored anesthesia

排除标准

  • •Patients who are taken directly to the ICU, ward, discharged, or transferred immediately after surgery.
  • •Patients who do not provide informed consent for enrollment in the study.

研究组 & 干预措施

Patients admitted to the postanesthesia care unit

Adult patients admitted to the postanesthesia care unit following surgery under general, regional, or monitored anesthesia

干预措施: Questionnaire and Physical Exam (Diagnostic Test)

结局指标

主要结局

Rate of patients with postoperative complications in the postanesthesia care unit

时间窗: 8 postoperative hours

Patients will be followed up during their stay in the PACU looking for the appearance of respiratory and hemodynamic complications, temperature disturbances or pain

次要结局

未报告次要终点

研究者

发起方
Ángel Becerra-Bolaños, MD PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ángel Becerra-Bolaños, MD PhD

Principal Investigator

Hospital Universitario de Gran Canaria Doctor Negrín

研究点 (8)

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