Intubation ComplicationCRICKETNCT05804188
CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
An observational study of Intubation Complication and Adverse Events, run by Thomas Riva at 8 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Intubation Complication, Adverse Events
- What is being tested?
- tracheal intubation
- How many people
- 105,000 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 8 Jan 2024to Jul 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: All paediatric patients requiring tracheal intubation due to their medical condition are screened if they fulfill the inclusion and exclusion criteria.
Who may be able to join
- 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.
Who cannot join
- Refusal to give consent or withdrawal of consent if such is required by the relevant ethics committee.
- Patients >16 years
Trial locations and contacts
8 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 5 countries
United States2 sites, 2 recruiting
- Recruiting
Department of Anesthesiology, Critical Care and Pain Medicine
Boston, Massachusetts, 02115
John Fiadjoe, Prof.
- Recruiting
Dept of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Annery Garcia-Marcinkiewicz, Prof.
Canada2 sites, 2 recruiting
- Recruiting
Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre
Montreal
Thomas Engelhardt, Prof.
- Recruiting
Dept. Anesthesia, The Hospital for Sick Children
Toronto, Ontario
Clyde Matava, Prof.
Switzerland2 sites, 2 recruiting
- Recruiting
Unité d'anesthésie pédiatrique, Hôpital des Enfants / HUG
Geneva, 1205
Habre Walid, Prof.
- Recruiting
Children's Hospital Zurich
Zurich, 8008
PD Dr. med. Alexander Schmidt, +41 44 249 7507, Alexander.schmidt@kispi.uzh.ch
Australia1 site, 1 recruiting
- Recruiting
Department of Anaesthesia and Pain Management, Perth Children's Hospital
Perth, 6009
Britta von Ungern-Sternberg, Prof. Dr.
Germany1 site, 1 recruiting
- Recruiting
Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin
Berlin
Maren Kleine-Brueggeney, Prof. Dr.
About this study
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.
Read the detailed description
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.
- Conditions
- Intubation Complication, Adverse Events
- Being tested
- tracheal intubation
- Keywords
- Intubation, Intratracheal, Anesthesiology, Difficult Airway, Critical events, Pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tracheal intubationOther
children between 0-16 requiring tracheal intubation
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Maximum of 30 days
Secondary outcomes (13)
Number of patients with severe hypoxemia
Oxygen saturation (SpO2) < 85% or >20 points below initial value at least 60 seconds
Measured: 1 hour
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
Measured: 1 hour
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
Measured: 1 hour
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
Measured: 1 hour
Number of patients with bronchospasm
Increased respiratory effort, especially during expiration, and wheeze on auscultation. Episode of bronchospasm requires the administration of a bronchodilator.
Measured: 1 hour
Number of patients with stridor after extubation
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.
Measured: 1 hour
Number of patients with obstruction of tracheal tube
Obstruction of tracheal tube needing lavage or tube exchange
Measured: 1 hour
Number of patients with airway bleeding
Acute bleeding from nose, arytenoids or pharynx causing obstruction or risk for pulmonary aspiration
Measured: 1 hour
Number of patients with can't intubate, can't oxygenate (CICO) situation
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
Measured: 1 hour
Number of patients with severe bradycardia/Cardiac arrest
Cessation of circulation (no pulse) or severe bradycardia (i.e. fibrillation/tachycardia) requiring chest compressions, during the intubation/extubation manoeuvres.
Measured: 1 hour
Number of patients with pulmonary aspiration
Presence of non-respiratory secretions (gastric, particulate, blood) in the airway as evidenced by (video-) laryngoscopy, suctioning, or bronchoscopy or radiologic signs.
Measured: 1 hour
Number of patients with pneumothorax/ pneumomediastinum
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.
Measured: 1 hour
Number of patients with negative pulmonary oedema
Non-cardiogenic pulmonary oedema that results from the generation of high negative intrathoracic pressure needed to overcome upper airway obstruction.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start8 Jan 2024
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Thomas Riva
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, The Hospital for Sick Children, Istituto Giannina Gaslini, Boston Children's Hospital, Boston, MA, USA
- Responsible party
- Sponsor-investigator, Thomas Riva, Insel Gruppe AG, University Hospital Bern
- Investigators
- Robert Greif, MD, Prof, Study chair, Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804188
- Sponsor's protocol ID
- Cricket 2023
- Other IDs
- 2023-00246, 2023
- Acronym
- CRICKET
- Status last verified
- May 2026
- First submitted
- 23 Mar 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bennett T, Disma N, Engelhardt T, Fiadjoe J, Fuchs A, Garcia-Marcinkiewicz A, Gregori D, Greif R, Habre W, Lorenzoni G, Kleine-Brueggeney M, Matava C, Maria Papappicco CA, Quintao VC, Riva T, von Ungern-Sternberg BS, Zoumenou E. Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation (CRICKET)-study protocol for an international multicentre prospective observational study. BJA Open. 2026 Feb 7;17:100523. doi: 10.1016/j.bjao.2025.100523. eCollection 2026 Mar.
PubMed 41705042
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
- ClinicalTrials.gov ID
- NCT05804188
- Acronym / sponsor ID
- CRICKET / Cricket 2023
- Conditions
- Intubation Complication, Adverse Events
- Keywords
- Intubation, Intratracheal, Anesthesiology, Difficult Airway, Critical events, Pediatrics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105,000 participants (estimated)
- Lead sponsor
- Thomas RivaUniversity, hospital or other
- Collaborators
- University of Bern, The Hospital for Sick Children, Istituto Giannina Gaslini, Boston Children's Hospital, Boston, MA, USA
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All paediatric patients requiring tracheal intubation due to their medical condition are screened if they fulfill the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Refusal to give consent or withdrawal of consent if such is required by the relevant ethics committee.
- Patients >16 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tracheal intubationchildren between 0-16 requiring tracheal intubation | Other | – |
Primary outcome
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).
13 secondary outcomes
Number of patients with severe hypoxemia
Time frame: 1 hour
Number of patients with severe bradycardia
Time frame: 1 hour
Number of patients with esophageal intubation
Time frame: 1 hour
Number of patients with laryngospasm
Time frame: 1 hour
Number of patients with bronchospasm
Time frame: 1 hour
Number of patients with stridor after extubation
Time frame: 1 hour
Number of patients with obstruction of tracheal tube
Time frame: 1 hour
Number of patients with airway bleeding
Time frame: 1 hour
Number of patients with can't intubate, can't oxygenate (CICO) situation
Time frame: 1 hour
Number of patients with severe bradycardia/Cardiac arrest
Time frame: 1 hour
Number of patients with pulmonary aspiration
Time frame: 1 hour
Number of patients with pneumothorax/ pneumomediastinum
Time frame: 1 hour
Number of patients with negative pulmonary oedema
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 41705042Bennett T, Disma N, Engelhardt T, Fiadjoe J, Fuchs A, Garcia-Marcinkiewicz A, Gregori D, Greif R, Habre W, Lorenzoni G, Kleine-Brueggeney M, Matava C, Maria Papappicco CA, Quintao VC, Riva T, von Ungern-Sternberg BS, Zoumenou E. Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation (CRICKET)-study protocol for an international multicentre prospective observational study. BJA Open. 2026 Feb 7;17:100523. doi: 10.1016/j.bjao.2025.100523. eCollection 2026 Mar.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Greif, MD, Prof study chair
Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation Complication and Adverse Events, run by Thomas Riva at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada, Switzerland, Australia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Riva, Prof. Dr. med (+41316322111, thomas.riva@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with critical events related to intubation (time frame: Maximum of 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05804188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.