CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation

NCT05804188 | Recruiting

• 2 other identifiers: Cricket 20232023-00246
• Study Type: observational
• Target: 105,000
• Locations: 5 countries
• Sites: 8

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.

Conditions

Intubation Complication; Adverse Events

Keywords

Intubation, Intratracheal; Anesthesiology; Difficult Airway; Critical events; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Number of patients with severe hypoxemia

  1 hour

• Number of patients with severe bradycardia

  1 hour

• Number of patients with esophageal intubation

  1 hour

• Number of patients with laryngospasm

  1 hour

• Number of patients with bronchospasm

  1 hour

Interventions

tracheal intubation OTHER

children between 0-16 requiring tracheal intubation

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Refusal to give consent or withdrawal of consent if such is required by the relevant ethics committee.
• Patients \>16 years

Sponsors & Collaborators

• Thomas Riva: lead
• University of Bern: collaborator
• The Hospital for Sick Children: collaborator
• Boston Children’s Hospital: collaborator
• Istituto Giannina Gaslini: collaborator

Study Sites (8)

Department of Anesthesiology, Critical Care and Pain Medicine

Boston, Massachusetts, 02115, United States

RECRUITING

Dept of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Department of Anaesthesia and Pain Management, Perth Children's Hospital

Perth, 6009, Australia

RECRUITING

Dept. Anesthesia, The Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre

Montreal, Canada

RECRUITING

Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin

Berlin, Germany

RECRUITING

Children's Hospital Zurich

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

Unité d'anesthésie pédiatrique, Hôpital des Enfants / HUG

Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Robert Greif, MD, Prof

  Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University

  STUDY CHAIR

Central Study Contacts

Thomas Riva, Prof. Dr. med

CONTACT

+41316322111; thomas.riva@insel.ch

Alex Fuchs, MD

CONTACT

+41 31 664 14 65; alexander.fuchs@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 7, 2023
• Study Start: January 8, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); CA (2); US (2); CH (2); AU (1)