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临床试验/NCT06117176
NCT06117176招募中不适用

Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care (PAPAYA III) - A European Multicentre Cross-sectional Observational Study

Insel Gruppe AG, University Hospital Bern5 个研究点 分布在 2 个国家目标入组 40,000 人开始时间: 2025年2月1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
40,000
试验地点
5
主要终点
Number of airway management related incidents

研究概览

简要总结

The overall objective of the study is to evaluate and analyze major and minor incidents during airway management in adults under anaesthesia care at all study sites. The patient characteristics, type of airway management is recorded and if airway management-related incidents occur, they are analyzed in more detail to improve patient safety in the future.

详细描述

It is a prospective observational cross-sectional European multi-centre study collecting health-related patient data on anaesthetic airway management over three months. This detects the incidence and nature of local airway management problems and assesses how they are solved. This will enable the investigators to identify generalisable interventions and recommendations to further improve patients' airway management to improve patient safety. During the observational period, the anaesthesia staff in charge will fill out a screening questionnaire for airway management for every patient undergoing anaesthesia care with airway management. The investigators will extract the characteristics from the local anaesthesia record system for all patients. If no event arises, there are no further requirements. If an event occurs, the anaesthesia provider will fill out an additional form asking for more details on what happened.

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

  • All adult patients requiring airway management under anaesthesia care for elective, semi-elective, urgent or emergency diagnostic procedures or interventions. Airway management includes awake and asleep tracheal intubation, insertion of supraglottic airway devices, and face mask ventilation.
  • Patients older than 18 years of age
  • Informed consent given or general consent in place, according to local ethics committee requirements.

排除标准

  • Refusal to give consent or withdrawal of consent.
  • Patients <18 years.

结局指标

主要结局

Number of airway management related incidents

时间窗: 30 days

Primary study outcome is the number of anaesthesia cases with at least one airway management related incidents in adult patients under anaesthesia care.

次要结局

  • The Incidences of the individual minor incidents(30 days)
  • The Incidences of the individual major incidents(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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