Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT02350933
Eligibility Criteria:
Inclusion Criteria:
* Planned elective intervention/surgery/diagnostics/endoscopy and general anaesthesia with airway instrumentation involving muscle paralysis in children, aged 1 month (UK) or from birth (other centers) to 16 years having prior prolonged (≥ 24h) tracheal intubation (s) during ICU-stay (s) within the study centre (patients for diagnosis/treatment of stridor are also included (see exclusion criteria also below)).
* No known risk for regurgitation
* Written parental consent
* American Society of Anesthesiologists (ASA) physical status \< IV
Exclusion Criteria:
* No parental written consent
* Known airway anomalies associated with syndromes
* Known or suspected difficult intubation
* Emergency surgery or intervention
* Full stomach and/or at risk for regurgitation
* ASA physical status IV and higher
* Patients with current or prior tracheostomy
* Known, suspected or potential cervical spine pathology (e.g. Down's Syndrome)
* Insufficient clinical details from previous prolonged intubation
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
16 Years
Study:
NCT02350933
Study Brief:
Protocol Section:
NCT02350933