Clinical trial NCT05804188: CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
Official title: CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intubation Complication
Adverse Events
Keywords: Intubation, Intratracheal
Anesthesiology
Difficult Airway
Critical events
Pediatrics
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
name: The Hospital for Sick Children
name: Boston Childrenâ€™s Hospital
name: Istituto Giannina Gaslini
First posted: 2023-04-07
Enrollment: 105000
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

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

Primary outcomes:
measure: Number of patients with critical events related to intubation
timeFrame: Maximum of 30 days
Secondary outcomes:
measure: Number of patients with severe hypoxemia
timeFrame: 1 hour
measure: Number of patients with severe bradycardia
timeFrame: 1 hour
measure: Number of patients with esophageal intubation
timeFrame: 1 hour
measure: Number of patients with laryngospasm
timeFrame: 1 hour
measure: Number of patients with bronchospasm
timeFrame: 1 hour
measure: Number of patients with stridor after extubation
timeFrame: 1 hour
measure: Number of patients with obstruction of tracheal tube
timeFrame: 1 hour
measure: Number of patients with airway bleeding
timeFrame: 1 hour
measure: Number of patients with can't intubate, can't oxygenate (CICO) situation
timeFrame: 1 hour
measure: Number of patients with severe bradycardia/Cardiac arrest
timeFrame: 1 hour
measure: Number of patients with pulmonary aspiration
timeFrame: 1 hour
measure: Number of patients with pneumothorax/ pneumomediastinum
timeFrame: 1 hour
measure: Number of patients with negative pulmonary oedema
timeFrame: 1 hour
Other outcomes:
Locations:
city: Boston
country: United States
facility: Department of Anesthesiology, Critical Care and Pain Medicine
state: Massachusetts
city: Philadelphia
country: United States
facility: Dept of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia
state: Pennsylvania
city: Perth
country: Australia
facility: Department of Anaesthesia and Pain Management, Perth Children's Hospital
city: Toronto
country: Canada
facility: Dept. Anesthesia, The Hospital for Sick Children
state: Ontario
city: Montréal
country: Canada
facility: Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre
city: Berlin
country: Germany
facility: Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin
city: Genève
country: Switzerland
facility: Unité d'anesthésie pédiatrique, Hôpital des Enfants / HUG
city: Zürich
country: Switzerland
facility: Children's Hospital Zurich
Study officials:
affiliation: Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University
name: Robert Greif, MD, Prof
role: STUDY_CHAIR
References: