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CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation

ConditionsIntubation ComplicationAdverse Events
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 16
SponsorThomas Riva

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Refusal to give consent or withdrawal of consent if such is required by the relevant ethics committee.

Patients >16 years

Trial population

All paediatric patients requiring tracheal intubation due to their medical condition are screened if they fulfill the inclusion and exclusion criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • tracheal intubation

    Other intervention

    children between 0-16 requiring tracheal intubation

Treatment groups

No treatment groups listed

Trial outcomes

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).

Time frame
Maximum of 30 days

Secondary outcomes

1

Number of patients with severe hypoxemia

Oxygen saturation (SpO2) \< 85% or \>20 points below initial value at least 60 seconds

Time frame
1 hour
2

Number of patients with severe bradycardia

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

Time frame
1 hour
3

Number of patients with esophageal intubation

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

Time frame
1 hour
4

Number of patients with laryngospasm

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

Time frame
1 hour

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Riva

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Sponsor institution

University of Bern

Collaborator

The Hospital for Sick Children

Collaborator

Istituto Giannina Gaslini

Collaborator

Boston Children's Hospital, Boston, MA, USA

Collaborator

Source ClinicalTrials.gov
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