CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation

Conditions
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Intubation Complication, Adverse Events

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Refusal to give consent or withdrawal of consent if such is required by the relevant ethics committee. Patients >16 years

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with critical events related to intubation | 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). | Maximum of 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with severe hypoxemia | Oxygen saturation (SpO2) < 85% or >20 points below initial value at least 60 seconds | 1 hour | 
| Number of patients with severe bradycardia | 0-3 months old: Heart rate (HR) < 80 bpm 4 months - 2 years: HR < 60 bpm 2-10 years old: HR < 40 bpm 10-16 years old: HR < 30 bpm at least 1 minute | 1 hour | 
| Number of patients with esophageal intubation | Tracheal tube placed in the oesophagus diagnosed by (video-) laryngoscopy, absence of sustained end-tidal carbon dioxide (EtCO2) trace, absence of lung ventilation (auscultation or absence of chest excursions) causing a drop in oxygenation | 1 hour | 
| Number of patients with laryngospasm | Complete airway obstruction associated with rigidity of the abdominal and chest walls and leading to unsuccessful child's ventilation, or glottic closure associated with chest movement but silent unsuccessful child's respiratory efforts and assisted ventilation, unrelieved in both situations with simple jaw thrust and continuous positive airway pressure (CPAP) manoeuvres and requiring the administration of medication (propofol, suxamethonium etc.) and/or tracheal (re)-intubation | 1 hour | 
| Number of patients with bronchospasm | Increased respiratory effort, especially during expiration, and wheeze on auscultation. Episode of bronchospasm requires the administration of a bronchodilator. | 1 hour | 
| Number of patients with stridor after extubation | Severe inspiratory flow limitation with sternal retraction, intrathoracic pressure swing, and potentially cyanosis occurring after extubation with or without the administration of oxygen, intravenous steroids and/or epinephrine (nebulization) or tracheal intubation. This can be documented clinically or with diagnostic examination, with persistence of symptoms. | 1 hour | 
| Number of patients with obstruction of tracheal tube | Obstruction of tracheal tube needing lavage or tube exchange | 1 hour | 
| Number of patients with airway bleeding | Acute bleeding from nose, arytenoids or pharynx causing obstruction or risk for pulmonary aspiration | 1 hour | 
| Number of patients with can't intubate, can't oxygenate (CICO) situation | Situation when there is failed intubation and failure to adequately oxygenate using facemask ventilation or supraglottic airway device resulting in increasing hypoxemia in an anaesthetised and paralysed patient | 1 hour | 
| Number of patients with severe bradycardia/Cardiac arrest | Cessation of circulation (no pulse) or severe bradycardia (i.e. fibrillation/tachycardia) requiring chest compressions, during the intubation/extubation manoeuvres. | 1 hour | 
| Number of patients with pulmonary aspiration | Presence of non-respiratory secretions (gastric, particulate, blood) in the airway as evidenced by (video-) laryngoscopy, suctioning, or bronchoscopy or radiologic signs. | 1 hour | 
| Number of patients with pneumothorax/ pneumomediastinum | Air in the thorax and/or mediastinum as consequence of tracheal intubation and ventilation, causing lung collapse or mediastinum dislodgment diagnosed by Lung-ultrasound and/or X-ray. | 1 hour | 
| Number of patients with negative pulmonary oedema | Non-cardiogenic pulmonary oedema that results from the generation of high negative intrathoracic pressure needed to overcome upper airway obstruction. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation, Intratracheal, Anesthesiology, Difficult Airway, Critical events, Pediatrics