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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
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Scientific title
CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
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Secondary ID [1]
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2023-00246
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Secondary ID [2]
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Cricket 2023
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Universal Trial Number (UTN)
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Trial acronym
CRICKET
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Intubation Complication
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0
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Adverse Events
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of patients with critical events related to intubation
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Assessment method [1]
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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).
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Timepoint [1]
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Maximum of 30 days
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Secondary outcome [1]
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Number of patients with severe hypoxemia
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Assessment method [1]
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Oxygen saturation (SpO2) \< 85% or \>20 points below initial value at least 60 seconds
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Timepoint [1]
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1 hour
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Secondary outcome [2]
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Number of patients with severe bradycardia
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Assessment method [2]
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0-3 months old: Heart rate (HR) \< 80 bpm
* 4 months - 2 years: HR \< 60 bpm
* 2-10 years old: HR \< 40 bpm
* 10-16 years old: HR \< 30 bpm at least 1 minute
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Timepoint [2]
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1 hour
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Secondary outcome [3]
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Number of patients with esophageal intubation
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Assessment method [3]
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Tracheal tube placed in the oesophagus diagnosed by (video-) laryngoscopy, absence of sustained end-tidal carbon dioxide (EtCO2) trace, absence of lung ventilation (auscultation or absence of chest excursions) causing a drop in oxygenation
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Timepoint [3]
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1 hour
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Secondary outcome [4]
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Number of patients with laryngospasm
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Assessment method [4]
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Complete airway obstruction associated with rigidity of the abdominal and chest walls and leading to unsuccessful child's ventilation, or glottic closure associated with chest movement but silent unsuccessful child's respiratory efforts and assisted ventilation, unrelieved in both situations with simple jaw thrust and continuous positive airway pressure (CPAP) manoeuvres and requiring the administration of medication (propofol, suxamethonium etc.) and/or tracheal (re)-intubation
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Timepoint [4]
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1 hour
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Secondary outcome [5]
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Number of patients with bronchospasm
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Assessment method [5]
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Increased respiratory effort, especially during expiration, and wheeze on auscultation. Episode of bronchospasm requires the administration of a bronchodilator.
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Timepoint [5]
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1 hour
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Secondary outcome [6]
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Number of patients with stridor after extubation
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Assessment method [6]
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Severe inspiratory flow limitation with sternal retraction, intrathoracic pressure swing, and potentially cyanosis occurring after extubation with or without the administration of oxygen, intravenous steroids and/or epinephrine (nebulization) or tracheal intubation. This can be documented clinically or with diagnostic examination, with persistence of symptoms.
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Timepoint [6]
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1 hour
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Secondary outcome [7]
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Number of patients with obstruction of tracheal tube
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Assessment method [7]
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Obstruction of tracheal tube needing lavage or tube exchange
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Timepoint [7]
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1 hour
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Secondary outcome [8]
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Number of patients with airway bleeding
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Assessment method [8]
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Acute bleeding from nose, arytenoids or pharynx causing obstruction or risk for pulmonary aspiration
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Timepoint [8]
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1 hour
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Secondary outcome [9]
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Number of patients with can't intubate, can't oxygenate (CICO) situation
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Assessment method [9]
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Situation when there is failed intubation and failure to adequately oxygenate using facemask ventilation or supraglottic airway device resulting in increasing hypoxemia in an anaesthetised and paralysed patient
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Timepoint [9]
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1 hour
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Secondary outcome [10]
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Number of patients with severe bradycardia/Cardiac arrest
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Assessment method [10]
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Cessation of circulation (no pulse) or severe bradycardia (i.e. fibrillation/tachycardia) requiring chest compressions, during the intubation/extubation manoeuvres.
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Timepoint [10]
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1 hour
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Secondary outcome [11]
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Number of patients with pulmonary aspiration
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Assessment method [11]
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Presence of non-respiratory secretions (gastric, particulate, blood) in the airway as evidenced by (video-) laryngoscopy, suctioning, or bronchoscopy or radiologic signs.
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Timepoint [11]
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1 hour
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Secondary outcome [12]
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Number of patients with pneumothorax/ pneumomediastinum
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Assessment method [12]
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Air in the thorax and/or mediastinum as consequence of tracheal intubation and ventilation, causing lung collapse or mediastinum dislodgment diagnosed by Lung-ultrasound and/or X-ray.
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Timepoint [12]
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1 hour
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Secondary outcome [13]
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Number of patients with negative pulmonary oedema
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Assessment method [13]
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Non-cardiogenic pulmonary oedema that results from the generation of high negative intrathoracic pressure needed to overcome upper airway obstruction.
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Timepoint [13]
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1 hour
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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.
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Minimum age
No limit
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Refusal to give consent or withdrawal of consent if such is required by the relevant ethics committee.
* Patients >16 years
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/01/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
105000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Department of Anaesthesia and Pain Management, Perth Children's Hospital - Perth
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Recruitment postcode(s) [1]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Massachusetts
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Country [2]
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United States of America
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State/province [2]
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Pennsylvania
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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Canada
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State/province [4]
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Montréal
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Country [5]
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Germany
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State/province [5]
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Berlin
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Country [6]
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Switzerland
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State/province [6]
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Genève
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Funding & Sponsors
Primary sponsor type
Other
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Name
Insel Gruppe AG, University Hospital Bern
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Bern
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Gaslini Children's Hospital
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Children's Hospital of Philadelphia
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Montreal Children's Hospital of the MUHC
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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The Hospital for Sick Children
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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Charite University, Berlin, Germany
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Address [6]
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Country [6]
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Other collaborator category [7]
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Other
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Name [7]
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Boston Children's Hospital
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Address [7]
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Country [7]
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Other collaborator category [8]
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Other
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Name [8]
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Perth Children's Hospital
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Address [8]
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Country [8]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05804188
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Robert Greif, MD, Prof
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Address
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Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Thomas Riva, MD, PD
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Address
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Country
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Phone
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+41 31 632 21 11
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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