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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05804188




Registration number
NCT05804188
Ethics application status
Date submitted
23/03/2023
Date registered
7/04/2023

Titles & IDs
Public title
CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
Scientific title
CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
Secondary ID [1] 0 0
2023-00246
Secondary ID [2] 0 0
Cricket 2023
Universal Trial Number (UTN)
Trial acronym
CRICKET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intubation Complication 0 0
Adverse Events 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with critical events related to intubation
Timepoint [1] 0 0
Maximum of 30 days
Secondary outcome [1] 0 0
Number of patients with severe hypoxemia
Timepoint [1] 0 0
1 hour
Secondary outcome [2] 0 0
Number of patients with severe bradycardia
Timepoint [2] 0 0
1 hour
Secondary outcome [3] 0 0
Number of patients with esophageal intubation
Timepoint [3] 0 0
1 hour
Secondary outcome [4] 0 0
Number of patients with laryngospasm
Timepoint [4] 0 0
1 hour
Secondary outcome [5] 0 0
Number of patients with bronchospasm
Timepoint [5] 0 0
1 hour
Secondary outcome [6] 0 0
Number of patients with stridor after extubation
Timepoint [6] 0 0
1 hour
Secondary outcome [7] 0 0
Number of patients with obstruction of tracheal tube
Timepoint [7] 0 0
1 hour
Secondary outcome [8] 0 0
Number of patients with airway bleeding
Timepoint [8] 0 0
1 hour
Secondary outcome [9] 0 0
Number of patients with can't intubate, can't oxygenate (CICO) situation
Timepoint [9] 0 0
1 hour
Secondary outcome [10] 0 0
Number of patients with severe bradycardia/Cardiac arrest
Timepoint [10] 0 0
1 hour
Secondary outcome [11] 0 0
Number of patients with pulmonary aspiration
Timepoint [11] 0 0
1 hour
Secondary outcome [12] 0 0
Number of patients with pneumothorax/ pneumomediastinum
Timepoint [12] 0 0
1 hour
Secondary outcome [13] 0 0
Number of patients with negative pulmonary oedema
Timepoint [13] 0 0
1 hour

Eligibility
Key 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.
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Refusal to give consent or withdrawal of consent if such is required by the relevant ethics committee.
* Patients >16 years

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
105000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Department of Anaesthesia and Pain Management, Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Montréal
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Switzerland
State/province [6] 0 0
Genève

Funding & Sponsors
Primary sponsor type
Other
Name
Insel Gruppe AG, University Hospital Bern
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Bern
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Gaslini Children's Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Children's Hospital of Philadelphia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Montreal Children's Hospital of the MUHC
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
The Hospital for Sick Children
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Charite University, Berlin, Germany
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Boston Children's Hospital
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Perth Children's Hospital
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Greif, MD, Prof
Address 0 0
Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Thomas Riva, MD, PD
Address 0 0
Country 0 0
Phone 0 0
+41 31 632 21 11
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05804188