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.
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.
Study Type
OBSERVATIONAL
Enrollment
105,000
children between 0-16 requiring tracheal intubation
Department of Anesthesiology, Critical Care and Pain Medicine
Boston, Massachusetts, United States
RECRUITINGDept of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGNumber 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).
Time frame: Maximum of 30 days
Number of patients with severe hypoxemia
Oxygen saturation (SpO2) \< 85% or \>20 points below initial value at least 60 seconds
Time frame: 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
Time frame: 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
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Department of Anaesthesia and Pain Management, Perth Children's Hospital
Perth, Australia
RECRUITINGDept. Anesthesia, The Hospital for Sick Children
Toronto, Ontario, Canada
RECRUITINGDept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre
Montreal, Canada
RECRUITINGDepartment of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin
Berlin, Germany
RECRUITINGChildren's Hospital Zurich
Zurich, Canton of Zurich, Switzerland
RECRUITINGUnité d'anesthésie pédiatrique, Hôpital des Enfants / HUG
Geneva, Switzerland
RECRUITINGTime frame: 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.
Time frame: 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.
Time frame: 1 hour
Number of patients with obstruction of tracheal tube
Obstruction of tracheal tube needing lavage or tube exchange
Time frame: 1 hour
Number of patients with airway bleeding
Acute bleeding from nose, arytenoids or pharynx causing obstruction or risk for pulmonary aspiration
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 hour