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:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-26 @ 10:32 AM
NCT ID:
NCT02201628
Eligibility Criteria:
Inclusion Criteria:
* Patient requires general anaesthesia with endotracheal intubation for a procedure assisted by radiography (e.g. line insertion, line change).
* Patient requires chest radiograph for procedure.
* Expected anaesthetic time more than 30 minutes.
Exclusion Criteria:
* No written parental written consent.
* Known oesophageal pathology (e.g. tracheo-oesophageal fistula, oesophageal strictures, oesophageal varices, oesophageal atresia).
* Known base of skull or midface fractures.
* Previous gastric bypass surgery or nasal surgery.
* Known coagulopathy.
* Previous alkaline ingestion.
* High aspiration risk.
* Significant respiratory co-morbidity requiring anticipated peak airway pressures \> 25 cm of water
* American Society Anaesthesiologists (ASA) grading 4 - 5.
* Tracheostomy in situ.
* Severe sepsis or septic shock or other other condition (such as bronchopulmonary fistula) that precludes use of tidal volume ventilation over 7 ml/kg.
* Known airway abnormalities (e.g. subglottic stenosis) that preclude placement of a MicroCuff® endotracheal tube.
* Oesophageal or nasopharyngeal probe contraindicated for reasons related to surgery / procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Months
Maximum Age:
7 Years
Study:
NCT02201628
Study Brief:
Protocol Section:
NCT02201628