Functional Residual Capacity Under Apnoeic Oxygenation with Different Flow Rates in Children (NCT05672329) | Clinical Trial Compass
CompletedNot Applicable
Functional Residual Capacity Under Apnoeic Oxygenation with Different Flow Rates in Children
Switzerland108 participantsStarted 2023-01-09
Plain-language summary
During induction of general anaesthesia physiological breathing stops and needs to be artificially established with facemask ventilation, and finally tracheal intubation or placement of a supraglottic airway. During the airway management, when lungs are not or only poorly ventilated, there is a risk for atelectasis. These atelectasis can contribute to respiratory adverse events (e.g. pulmonary infection or respiratory insufficiency) during or after general anaesthesia. High-flow nasal oxygen (HFNO) is the administration of heated, humidified and blended air/oxygen mixture via a nasal cannula at rates ≥ 2 L/kg/min. HFNO used during airway management (i.e. intubation) can extend the tolerance for apnea, the time from end of physiological breathing until artificial ventilation is established. The main objective of this study is thus to investigate the variations of poorly ventilated lung units (i.e., silent spaces) as a surrogate for functional residual capacity measured by electrical impedance tomography to dynamically assess atelectasis formation and regression under apnoeic oxygenation with different flow rates.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent by legal guardian
* Paediatric patients undergoing elective surgery requiring general anaesthesia at the Bern University Hospital - Inselspital in Bern
* Child weight between 10-20kg
* American Society of Anesthesiology (ASA) physical status 1 \& 2 (healthy child, no severe co-morbidities)
Exclusion Criteria:
* Known or suspected difficult intubation
* Oxygen dependency
* Congenital heart or lung disease
* Obesity BMI (kg/m2) \>30
* High aspiration risk (requiring rapid sequence intubation).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.