CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Thomas Riva
- 入组人数
- 105,000
- 试验地点
- 14
- 主要终点
- Number of patients with critical events related to intubation
研究概览
简要总结
The investigators' overall objective is to assess the incidence of critical events related to tracheal intubation at all international study sites. Furthermore, the study will investigate the used intubation techniques and identify possible improvement measures to increase patient safety.
详细描述
It is a prospective observational multi-centre study collecting health related patient data over a period of three months. This serves best the study's purpose to detect the incidence and nature of problems related to tracheal intubation and how such problems are handled with the aim to further improve patient safety. During the observational period the anaesthesia staff in charge will complete a screening questionnaire for critical events associated with tracheal intubation for every patient undergoing general anaesthesia with tracheal intubation. If no critical events arise there are no further requirements. If a critical event occurs, the anaesthesia provider will complete a more detailed questionnaire which includes more questions about what exactly happened.
Patient characteristics will be extracted from the anaesthesia records. The investigators will extract such data for all patients undergoing tracheal intubation and additional data for those with critical events. The research will not intervene with the clinical conduct of patient care.
The collected health related data will be transferred to an electronic research data base. In this data base data will be encoded. Every patient with a critical event will be followed up as described above.
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
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All paediatric patients requiring tracheal intubation, performed by the anaesthesia team for procedures or interventions requiring general anaesthesia
- •Patients from 0 - 16 years of age.
- •Informed or general consent given, according to the relevant ethics committee statement.
排除标准
- •Refusal to give consent or withdrawal of consent if such is required by the relevant ethics committee.
- •Patients >16 years
结局指标
主要结局
Number of patients with critical events related to intubation
时间窗: Maximum of 30 days
Primary study outcome is the incidence of anaesthesia cases with critical events associated with endotracheal intubation requiring intervention from the start of anaesthesia until the discharge of the patient from the post-anaesthesia care unit or end of anaesthesia (defined as handover to the paediatric or neonatal intensive care unit, the ward or discharge home straight from anaesthesia care) in children aged 0 - 16 years. Facultatively for those who do not have capacity the acquisition of data stops at the end of anaesthesia (defined as handover to the post-anaesthesia care unit).
次要结局
- Number of patients with laryngospasm(1 hour)
- Number of patients with bronchospasm(1 hour)
- Number of patients with airway bleeding(1 hour)
- Number of patients with can't intubate, can't oxygenate (CICO) situation(1 hour)
- Number of patients with severe hypoxemia(1 hour)
- Number of patients with severe bradycardia(1 hour)
- Number of patients with stridor after extubation(1 hour)
- Number of patients with pulmonary aspiration(1 hour)
- Number of patients with esophageal intubation(1 hour)
- Number of patients with obstruction of tracheal tube(1 hour)
- Number of patients with pneumothorax/ pneumomediastinum(1 hour)
- Number of patients with severe bradycardia/Cardiac arrest(1 hour)
- Number of patients with negative pulmonary oedema(1 hour)
研究者
Thomas Riva
Prof. Dr. med.
Insel Gruppe AG, University Hospital Bern