This randomized controlled multi-centre trial in children from birth up to \< 5 years of age aims to demonstrate equivalence as to the major outcome of post-extubation airway injury (stridor) comparing uncuffed tracheal tubes to current tracheal tubes with modern high volume - low pressure cuff combined with a cuff pressure release valve.
Who can participate
Age range1 Day – 5 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children aged from birth (weighing \> 3 kg) to \<5 years
* Children requiring oro-tracheal or naso-tracheal intubation with a Magil shaped tracheal tube or preformed (RAE) tracheal tube as a part of their anaesthetic care and planed IPPV during the surgical / interventional / diagnostic procedure
* Tracheal intubation performed using direct laryngoscopy
* Extubation after the procedure in the OR theatre
* Procedure performed in supine position
* Patients for elective and emergency surgery and/or interventions if there is no risk for regurgitation or pulmonary aspiration
* ASA I and II patients
* Written parental consent
Exclusion Criteria:
* No parental written consent obtained
* Known airway anomalies (airway stenosis, including Down's Syndrome)
* Known or suspected difficult intubation
* Known need for abnormal tube size
* Full stomach and/or at risk for regurgitation
* Surgery of the larynx and/or of the trachea and/or neck and/or upper oesophagus
* Pulmonary diseases (concurrent pneumonia or bronchial infection, asthma requiring inhalation medication, pulmonary malformations)
* ASA class III and higher
* Fiberoptic intubation or alternative intubation technique
* Patients planned for postoperative ventilation in the ICU
* Weight and/or height percentiles \< 3% / \> 97%