跳至主要内容
临床试验/NCT06033404
NCT06033404招募中不适用

Registry of Patients Undergoing Anesthesia or Intensive Care Maneuvers

Università Vita-Salute San Raffaele1 个研究点 分布在 1 个国家目标入组 30,000 人开始时间: 2023年7月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30,000
试验地点
1
主要终点
Clinical outcomes of patients urdergoing anesthesia and/or critical care

研究概览

简要总结

In recent decades, knowledge in the anesthesiology field has increasingly expanded, allowing for the refinement of monitoring techniques, therapies, and local-regional anesthesia maneuvers, and for the extension of care to a larger number of patients, including those previously excluded due to advanced age or comorbidities. Similarly, Intensive care management has continuously evolved, following innovations in the field of drugs and with the great diffusion of extracorporeal supports. The fundamental importance of registry studies has been recognized in this context to rapidly generate reliable data and improve the quality of care.

This prospective observational study is aimed at collecting data of all patients (expected 300,000) undergoing anesthesia or intensive care maneuvers at our institution. This registry aims to assist in carrying out registry-based clinical studies focused on improving current therapeutic and patient management standards.

详细描述

The study aims to collect data on 300,000 patients who undergo anesthesia and/or resuscitation procedures at the IRCCS San Raffaele Scientific Institute over a 10 years period. The information collected will include demographic data, anthropometric data, past and/or current clinical history of the patient, anamnestic clinical-instrumental data related to the anesthetic activity, data on therapeutic measures taken during stay in intensive care units, laboratory parameters, diagnostic tests, therapeutic procedures carried out during hospitalization, patient satisfaction, and evaluation scales. All this data will be anonymized prior insertion in the database, with the aim of creating a registry that can be used for scientific research. This registry aims to assist in carrying out registry-based clinical studies focused on improving current therapeutic and patient management standards. The duration of observation of each patient will be variable, depending on the length of hospital stay and/or the duration of the diagnostic-therapeutic process. The analysis will follow the clinical course of patients from admission to hospital discharge, with the possibility of conducting telephone follow-ups for certain categories of patients after 1 year. Statistical analyses will be performed by grouping or describing patients based on their characteristics or in relation to the type of anesthetic and resuscitation procedures they undergo.

This study will follow the ethical principles outlined in the Helsinki Declaration and the current regulations for Observational Studies. All patients will be fully informed about the aspects of the study and their written informed consent will be required before participation.

Participation in the study is voluntary and free. No additional costs are expected for data collection and analysis: given the observational nature of the study, insurance coverage is not required.

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

入选标准

  • Patients undergoing Anesthesia or Critical care
  • Signed informed consent.

排除标准

  • Refused informed consent

结局指标

主要结局

Clinical outcomes of patients urdergoing anesthesia and/or critical care

时间窗: hospital discharge (usually <=30 days)

This study will collect data on the anesthesia-related and hospital outcome of patients undergoing anesthesia and intensive care. Due to the large sample size and heterogeneity of populations, further analysis will be planned to address homogenenous subgroups of patients.

次要结局

未报告次要终点

研究者

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

Giovanni Landoni

MD, Full Professor

Università Vita-Salute San Raffaele

研究点 (1)

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