Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation (CRICKET)-study protocol for an international multicentre prospective observational study.
Tom Bennett, Nicola Disma, Thomas Engelhardt...
https://pubmed.ncbi.nlm.nih.gov/41705042Actively Recruiting
Age: 0 - 16Years
All Genders
ID05804188
CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
Led by Thomas Riva · Updated on 2026-05-12
105000
Participants Needed
8
Research Sites
4 weeks
Total Duration
On this page
Sponsors
T
Thomas Riva
Lead Sponsor
U
University of Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a prospective observational study across multiple centers to assess the frequency and nature of critical events related to tracheal intubation in children undergoing general anesthesia. The goal is to understand problems that occur during intubation and identify ways to improve patient safety without interfering with standard care. This study focuses on pediatric patients from birth to 16 years old. During the three-month observation period, anesthesia staff will complete a screening questionnaire for every child requiring tracheal intubation. If a critical event occurs during intubation, a more detailed questionnaire will be filled out to document exactly what happened. Patient data will be collected from anesthesia records and securely stored in an electronic database. Each patient with a critical event will be closely followed up according to the study protocol. Participants are involved only through data collection and questionnaires completed by anesthesia providers. The research team will review various critical events such as severe hypoxemia, bradycardia, airway obstruction, and other complications within one hour of intubation. The primary outcome is the number of patients with critical intubation-related events tracked up to 30 days. The study will not change patient treatment and focuses on improving future safety practices.
CONDITIONS
Brief Title
CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
Who Can Participate
Age: 0 - 16Years
All Genders
Eligibility Criteria
You may qualify if you...
- All paediatric patients requiring tracheal intubation performed by the anaesthesia team for procedures or interventions needing general anaesthesia
- Patients from 0 to 16 years of age
- Informed or general consent given according to the relevant ethics committee statement
You will not qualify if you...
- Refusal to give consent or withdrawal of consent if required by the relevant ethics committee
- Patients older than 16 years
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 3 months
Participants undergoing tracheal intubation are observed to detect the incidence and nature of critical events related to the procedure. Health data and critical event questionnaires are collected during the observational period.
Data collected during routine care; no additional visits required
Follow-up
Duration - Up to 30 days after critical event
Participants who experience critical events related to intubation are followed up with additional detailed data collection to understand the event and patient outcomes.
Additional assessments as needed depending on occurrence of critical events
Trial Site Locations
Total: 8 locations
1
Department of Anesthesiology, Critical Care and Pain Medicine
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dept of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
3
Department of Anaesthesia and Pain Management, Perth Children's Hospital
Perth, Australia, 6009
Actively Recruiting
4
Dept. Anesthesia, The Hospital for Sick Children
Toronto, Ontario, Canada
Actively Recruiting
5
Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre
Montreal, Canada
Actively Recruiting
6
Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin
Berlin, Germany
Actively Recruiting
7
Unité d'anesthésie pédiatrique, Hôpital des Enfants / HUG
Geneva, Switzerland, 1205
Actively Recruiting
8
Children's Hospital Zurich
Zurich, Switzerland, 8008
Actively Recruiting
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Research Team
T
Thomas Riva, Prof. Dr. med
A
Alexander Fuchs, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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