CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation (CRICKET)

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.

Study Overview

• Status: Recruiting
• Conditions: Intubation Complication; Adverse Events
• Intervention / Treatment: Other: tracheal intubation

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 105000

Contacts and Locations

• Study Contact: Name: Thomas Riva, Prof. Dr. med; Phone Number: +41316322111; Email: thomas.riva@insel.ch
• Study Contact Backup: Name: Alexander Fuchs, MD; Phone Number: +41 31 663 23 84; Email: alexander.fuchs@insel.ch

Study Locations

• Australia
  • Perth, Australia, 6009
    • Recruiting
    • Department of Anaesthesia and Pain Management, Perth Children's Hospital
    • Contact: Britta von Ungern-Sternberg, Prof. Dr.
• Canada
  • Montreal, Canada
    • Recruiting
    • Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre
    • Contact: Thomas Engelhardt, Prof.
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • Dept. Anesthesia, The Hospital for Sick Children
      • Contact: Clyde Matava, Prof.
• Germany
  • Berlin, Germany
    • Recruiting
    • Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin
    • Contact: Maren Kleine-Brueggeney, Prof. Dr.
• Switzerland
  • Geneva, Switzerland, 1205
    • Recruiting
    • Unité d'anesthésie pédiatrique, Hôpital des Enfants / HUG
    • Contact: Habre Walid, Prof.
  • Zurich, Switzerland, 8008
    • Recruiting
    • Children's Hospital Zurich
    • Contact: PD Dr. med. Alexander Schmidt; Phone Number: +41 44 249 7507; Email: Alexander.schmidt@kispi.uzh.ch
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Department of Anesthesiology, Critical Care and Pain Medicine
      • Contact: John Fiadjoe, Prof.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Dept of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia
      • Contact: Annery Garcia-Marcinkiewicz, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All paediatric patients requiring tracheal intubation due to their medical condition are screened if they fulfill the inclusion and exclusion criteria.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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 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
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

Collaborators and Investigators

• Sponsor: Thomas Riva
• Collaborators: The Hospital for Sick Children; University of Bern; Istituto Giannina Gaslini; Boston Children's Hospital, Boston, MA, USA
• Investigators: Study Chair: Robert Greif, MD, Prof, Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University

Publications and helpful links

General Publications

• Bennett T, Disma N, Engelhardt T, Fiadjoe J, Fuchs A, Garcia-Marcinkiewicz A, Gregori D, Greif R, Habre W, Lorenzoni G, Kleine-Brueggeney M, Matava C, Maria Papappicco CA, Quintao VC, Riva T, von Ungern-Sternberg BS, Zoumenou E. Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation (CRICKET)-study protocol for an international multicentre prospective observational study. BJA Open. 2026 Feb 7;17:100523. doi: 10.1016/j.bjao.2025.100523. eCollection 2026 Mar.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pediatrics; Difficult Airway; Anesthesiology; Intubation, Intratracheal; Critical events
• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutics; Airway Management; Intubation; Intubation, Intratracheal
• Other Study ID Numbers: Cricket 2023; 2023-00246 (Registry Identifier: Swissethics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No