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NCT Number: NCT05804188

CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation

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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Key information

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

It is a prospective observational multi-centre study collecting health related patient data over a period of three months. This serves best the study's purpose to detect the incidence and nature of problems related to tracheal intubation and how such problems are handled with the aim to further improve patient safety. During the observational period the anaesthesia staff in charge will complete a screening questionnaire for critical events associated with tracheal intubation for every patient undergoing general anaesthesia with tracheal intubation. If no critical events arise there are no further requirements. If a critical event occurs, the anaesthesia provider will complete a more detailed questionnaire which includes more questions about what exactly happened.

Patient characteristics will be extracted from the anaesthesia records. The investigators will extract such data for all patients undergoing tracheal intubation and additional data for those with critical events. The research will not intervene with the clinical conduct of patient care.

The collected health related data will be transferred to an electronic research data base. In this data base data will be encoded. Every patient with a critical event will be followed up as described above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

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

Treatment and study plan

Tracheal intubation

Other

children between 0-16 requiring tracheal intubation

Primary outcomes

  1. Number of patients with critical events related to intubation

    Time frame: Maximum of 30 days

    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).

Secondary outcomes

  1. Number of patients with severe hypoxemia

    Time frame: 1 hour

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

  2. Number of patients with severe bradycardia

    Time frame: 1 hour

    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
  3. Number of patients with esophageal intubation

    Time frame: 1 hour

    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

  4. Number of patients with laryngospasm

    Time frame: 1 hour

    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

  5. Number of patients with bronchospasm

    Time frame: 1 hour

    Increased respiratory effort, especially during expiration, and wheeze on auscultation. Episode of bronchospasm requires the administration of a bronchodilator.

  6. Number of patients with stridor after extubation

    Time frame: 1 hour

    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.

  7. Number of patients with obstruction of tracheal tube

    Time frame: 1 hour

    Obstruction of tracheal tube needing lavage or tube exchange

  8. Number of patients with airway bleeding

    Time frame: 1 hour

    Acute bleeding from nose, arytenoids or pharynx causing obstruction or risk for pulmonary aspiration

  9. Number of patients with can't intubate, can't oxygenate (CICO) situation

    Time frame: 1 hour

    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

  10. Number of patients with severe bradycardia/Cardiac arrest

    Time frame: 1 hour

    Cessation of circulation (no pulse) or severe bradycardia (i.e. fibrillation/tachycardia) requiring chest compressions, during the intubation/extubation manoeuvres.

  11. Number of patients with pulmonary aspiration

    Time frame: 1 hour

    Presence of non-respiratory secretions (gastric, particulate, blood) in the airway as evidenced by (video-) laryngoscopy, suctioning, or bronchoscopy or radiologic signs.

  12. Number of patients with pneumothorax/ pneumomediastinum

    Time frame: 1 hour

    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.

  13. Number of patients with negative pulmonary oedema

    Time frame: 1 hour

    Non-cardiogenic pulmonary oedema that results from the generation of high negative intrathoracic pressure needed to overcome upper airway obstruction.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Fuchs, MD

CONTACT

[email protected]

+41 31 663 23 84

Thomas Riva, Prof. Dr. med

CONTACT

[email protected]

+41316322111

Sponsors and collaborators

Lead sponsor

Thomas Riva

Other

Collaborators

  • Boston Children's Hospital, Boston, MA, USA
  • Istituto Giannina Gaslini
  • The Hospital for Sick Children
  • University of Bern

Registry information

Acronym: CRICKET

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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