CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tracheal intubation.
- Who it may be relevant to
- Registry conditions: Intubation Complication, Adverse Events. Basic parameters: up to 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, Germany, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Interventions
- Other tracheal intubation
children between 0-16 requiring tracheal intubation
Primary outcome measures
- Number of patients with critical events related to intubation [Time frame: Maximum of 30 days]
Secondary outcome measures (12)
- Number of patients with severe hypoxemia [Time frame: 1 hour]
- Number of patients with severe bradycardia [Time frame: 1 hour]
- Number of patients with esophageal intubation [Time frame: 1 hour]
- Number of patients with laryngospasm [Time frame: 1 hour]
- Number of patients with bronchospasm [Time frame: 1 hour]
- Number of patients with stridor after extubation [Time frame: 1 hour]
- Number of patients with obstruction of tracheal tube [Time frame: 1 hour]
- Number of patients with airway bleeding [Time frame: 1 hour]
- Number of patients with can't intubate, can't oxygenate (CICO) situation [Time frame: 1 hour]
- Number of patients with severe bradycardia/Cardiac arrest [Time frame: 1 hour]
- Number of patients with pulmonary aspiration [Time frame: 1 hour]
- Number of patients with pneumothorax/ pneumomediastinum [Time frame: 1 hour]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Department of Anesthesiology, Critical Care and Pain Medicine — Boston
- Dept of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia — Philadelphia
Canada · 2 centers
- Dept. Anesthesia, The Hospital for Sick Children — Toronto
- Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre — Montreal
Switzerland · 2 centers
- Unité d'anesthésie pédiatrique, Hôpital des Enfants / HUG — Geneva
- Children's Hospital Zurich — Zurich
Australia · 1 center
- Department of Anaesthesia and Pain Management, Perth Children's Hospital — Perth
Germany · 1 center
- Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedi — Berlin
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. 2 PMID 41705042
Identifiers
NCT: NCT05804188 · Cricket 2023 · 2023-00246