CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation

Intubation Complication Clinical Trial

— CRICKET  

Official title:

CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05804188
• Other study ID #: Cricket 2023
• Secondary ID: 2023-00246
• Status: Recruiting
• Start date: January 8, 2024
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Thomas Riva, MD, PD
• Phone: +41 31 632 21 11
• Email: thomas.riva[@]insel.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Events
• Intubation Complication

Locations

Country	Name	City	State
Australia	Department of Anaesthesia and Pain Management, Perth Children's Hospital	Perth
Canada	Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre	Montréal
Canada	Dept. Anesthesia, The Hospital for Sick Children	Toronto	Ontario
Germany	Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin	Berlin
Switzerland	Unité d'anesthésie pédiatrique, Hôpital des Enfants / HUG	Genève
United States	Department of Anesthesiology, Critical Care and Pain Medicine	Boston	Massachusetts
United States	Dept of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (9)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	Boston Children's Hospital, Charite University, Berlin, Germany, Children's Hospital of Philadelphia, Gaslini Children's Hospital, Montreal Children's Hospital of the MUHC, Perth Children's Hospital, The Hospital for Sick Children, University of Bern

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients with severe hypoxemia	Oxygen saturation (SpO2) < 85% or >20 points below initial value at least 60 seconds	1 hour
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients with obstruction of tracheal tube	Obstruction of tracheal tube needing lavage or tube exchange	1 hour
Secondary	Number of patients with airway bleeding	Acute bleeding from nose, arytenoids or pharynx causing obstruction or risk for pulmonary aspiration	1 hour
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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