INternational Observational Study To Understand the Impact and BEst Practices of Airway Management in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,600
- 试验地点
- 1
- 主要终点
- Major intubation-related complication
研究概览
简要总结
Endotracheal intubation (ETI) is a potentially life-threatening procedure for critically ill patients and major severe complications such as severe hypoxia, cardiovascular collapse and cardiac arrest are common. Despite the high risk of the procedure, different interventions lack high-quality evidence and the investigators hypothesize that a heterogeneous practice among different centres and geographical areas may be found.
The investigators designed a large international observational study aiming at prospectively collecting data on the current impact of ETI-related adverse events and current airway management practice in critically ill patients. Investigators will collect data on all consecutive in-hospital (intensive care unit, emergency department and wards) ETIs performed in adult critically patients.
详细描述
This study aims at prospectively collecting data on the current morbidity and mortality of ETI-related adverse events and current airway management practice in adult critically ill patients. Investigators designed a large international study calling for participation all institutions caring critically ill patients worldwide.
Inclusion criteria
Investigators will include all adult (≥ 18 years old) critically ill patients undergoing intubation during the period of observation. Investigators will consider all in-hospital intubations. Critically ill will be defined those patients with a life-threatening condition requiring intubation for either cardiorespiratory failure or airway protection.
Exclusion Criteria
- Intubation performed in the out-of-hospital setting
- Intubation during cardiac arrest
- Intubation performed for anaesthesia
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
- •Critically ill patients undergoing in-hospital endotracheal intubation.
排除标准
- •Intubation performed in the out-of-hospital setting;
- •Intubation during cardiac arrest;
- •Intubation performed only for anaesthesia.
结局指标
主要结局
Major intubation-related complication
时间窗: 30 minutes
At least one of the following (composite outcome): * Severe hypoxemia (SpO2 \< 80%) occurring within 30 minutes from intubation * Cardiac arrest occurring within 30 minutes from intubation * Cardiovascular collapse (at least one of the following), occurring within 30 minutes from intubation: * Systolic arterial pressure \< 65 mmHg recorded 1 time * SAP \< 90 mmHg for \> 30 minutes * New need of vasopressors/their increase and/or fluid load \> 15 ml/kg to maintain the target blood pressure.
次要结局
- Aspiration of gastric contents(24 hours)
- Difficult intubation(30 minutes)
- Oesophageal intubation(30 minutes)
- Airways injury(24 hours)
- Cardiac arrhythmia(30 minutes)
- Cannot intubate cannot oxygenate scenario (CICO)(30 minutes)
- ICU mortality(up to 12 weeks)
- Emergency front of neck airway (FONA)(30 minutes)
- Pneumothorax/pneumo-mediastinum(24 hours)
- Dental injury(24 hours)
研究者
Vincenzo Russotto, MD
MD
Azienda Ospedaliera San Gerardo di Monza