Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study. The Crush or Crash Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,150
- 试验地点
- 30
- 主要终点
- Occurrence of a major haemodynamic disorder
研究概览
简要总结
There is a great heterogeneity in the practice of rapid sequence induction in the operating room in the world. There are no recent data assessing the rate of implementation of the latest French formalized expert recommendations in clinical practice. In addition, the modalities for the management of haemodynamic disorders, particularly hypotensive disorders, during rapid sequence induction are not described in these recommendations, although these are frequent events with a non-zero morbidity mortality potential.
The goal of this prospective, observational, multicenter, anesthetic study is to describe the clinical practice of French anesthesiologists regarding the prevention of severe hemodynamic disorders during rapid sequence anesthetic induction in adult patients.
The primary outcome measure is the occurrence of a major haemodynamic disorder defined by a MBP ≤ 50 mmHg (or ≤ 40% of the reference value) and/or ≥ 110 mmHg and/or the occurrence of sustained arrhythmia not present at induction and/or cardiac arrest within the first 10 minutes after induction of anesthesia.
The clinical practices of pre-oxygenation, induction and intubation of French anesthesiologists and compliance with the formalized expert recommendations of 2017 and 2018 will also be studied secondarily. The elements for the prevention of gastric fluid inhalation, the organization and equipment used, the anesthetic and non-anesthetic drugs used, the clinical and paraclinical neurological and cardio-respiratory parameters and the nature of the complications following anaesthetic induction will be collected up to the 10th post-induction minute.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age ≥ 18 years' old
- •Procedure requiring general anesthesia with oro or nasotracheal intubation
- •Anesthetic management with indication of rapid sequence induction
- •No objection after oral and written information to the patient
排除标准
- •Age < 18 years' old
- •Impossible intubation planned
- •Preoperative respiratory distress (SpO2 < 90% in ambient air)
- •Preoperative shock (MBP≤ 65 mmHg or vasopressive amines)
- •Preoperative coma defined by a Glasgow score ≤ 12/15
- •Patient in cardiopulmonary arrest
- •Patients under guardianship or curatorship
结局指标
主要结局
Occurrence of a major haemodynamic disorder
时间窗: Within the first 10 minutes after induction of anesthesia
MBP ≤ 50 mmHg (or ≤ 40% of the reference value) and/or ≥ 110 mmHg and/or occurrence of a sustained arrhythmia (\> 1 min) not present at induction and/or cardiac arrest
次要结局
- Clinical pre-anesthesic assessment of the risk of a full stomach(From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure)
- Pre-anesthetic assessment of the risk of a full stomach(From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure)
- Team involved in the rapid sequence induction technique(Within the first 10 minutes after induction of anesthesia)
- Preparation for rapide sequence induction technique(Within the first 10 minutes after induction of anesthesia)
- Use of morphine for rapid sequence induction technique(Within the first 10 minutes after induction of anesthesia)
- Induction therapeutics for rapid sequence induction technique(Within the first 10 minutes after induction of anesthesia)
- Assessment of the risk of a full stomach(From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure)
- Use of curare for rapid sequence induction technique(Within the first 10 minutes after induction of anesthesia)
- Use of vasopressive amine for rapid sequence induction technique(Within the first 10 minutes after induction of anesthesia)
- Use of filling solution for rapid sequence induction technique(Within the first 10 minutes after induction of anesthesia)
- Airway management for rapid sequence induction technique(Within the first 10 minutes after induction of anesthesia)
- Operator qualification for rapid sequence induction technique(Within the first 10 minutes after induction of anesthesia)
- Laryngoscopy for rapid sequence induction technique(Within the first 10 minutes after induction of anesthesia)
- Cardiac complications of ISR (< 10 minutes)(Within the first 10 minutes after induction of anesthesia)
- Intubation complications of ISR (< 10 minutes)(Within the first 10 minutes after induction of anesthesia)
- Medical device used for rapid sequence induction technique(Within the first 10 minutes after induction of anesthesia)
- MBP complications of ISR (< 10 minutes)(Within the first 10 minutes after induction of anesthesia)
- Low tension-related complications of ISR (< 10 minutes)(Within the first 10 minutes after induction of anesthesia)
- Tension complications of ISR (< 10 minutes)(Within the first 10 minutes after induction of anesthesia)
- Rythmal complications of ISR (< 10 minutes)(Within the first 10 minutes after induction of anesthesia)
- High tension-related complications of ISR (< 10 minutes)(Within the first 10 minutes after induction of anesthesia)
- Respiratory complications of ISR (< 10 minutes)(Within the first 10 minutes after induction of anesthesia)
- Anaphylactic complications of ISR (< 10 minutes)(Within the first 10 minutes after induction of anesthesia)
- Inhalation complications of ISR (< 10 minutes)(Within the first 10 minutes after induction of anesthesia)
- Immediate complications of ISR (< 10 minutes)(Within the first 10 minutes after induction of anesthesia)