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临床试验/NCT05440331
NCT05440331招募中不适用

Morbidity and Mortality in Operating Room: Surgery and Standardized Communication

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 1,120 人开始时间: 2023年9月8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
1,120
试验地点
1
主要终点
The occurence of adverse events

研究概览

简要总结

The primary objective of the study is to evaluate the efficacy of standard handover with AnesList© between physician anesthesists in operating room, for a complete transmission for a patient, on the occurence of event as death, serious complications or rehospitalization in month of postoperative after major surgery.

详细描述

The secondary objectives are:

  • to analysis the impact of the transmission on:
  1. the occurence of different events: re-hospitalization, serious complications, death at one month;
  2. the duration of initial ICU stay and of hospitalization;
  3. the duration of the transmission;
  4. the quality of the transmission by the physician leaving operating room.
  • to evaluate the condition of the transmission
  • to study the persistence of the use of the AnesList© at 6 months after the end of inclusions in the center
  • to evaluate the satisfaction on AnesList© and on the training with the tool and the obstacles of its utilization
  • to evaluate the morbility-mortality in the centers of the centers before, during and 6 months after the beginning of the study.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Patient aged > 18 years;
  • Patients with score ASA I-IV;
  • Requiring urgent or planned surgery;
  • Major surgery (duration of surgery > 2 hours, requiring a hospital stay of at least 1 night): orthopedics, cardiac, vascular, thoracic, visceral, ENT, plastic surgery;
  • Handover between two anesthesists defined as a definitive relay between one physician anaesthesist and another in operating room;
  • Intensive care anesthesists and nurse anaesthetist working in investigator center during the study;
  • Affiliated to a social security system;
  • No-opposition to participating to the study.

排除标准

  • Transmission between physician anaesthesist and nurse anaesthetist;
  • Medical transmission occurs out of anesthesia care out of operating room;
  • Medical transmission occurs in transitory manner (for example: coffee time, lunch time);
  • Patients enrolled in an another ongoing study of surgical intervention.

结局指标

主要结局

The occurence of adverse events

时间窗: at 1 month

Death, serious complications and re-hospitalization will be noted in order to evaluate the efficacy of standardized transmission with AnesList©.

次要结局

  • Evaluate of the condition of transmission(through study completion, an average of 18 months)
  • Morbi-mortality(through study completion, an average of 18 months)
  • The duration of ICU stay(through study completion, an average of 18 months)
  • The duration of hospitalization(through study completion, an average of 18 months)
  • Utilization of the AnesList© by anaesthesists at 6 months(at 6 months)
  • Interaction with study nurse(through study completion, an average of 18 months)
  • Quality of medical transmission(through study completion, an average of 18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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