Effect of Sedation on Pulmonary Aeration in Children (NCT03392012) | Clinical Trial Compass
UnknownNot Applicable
Effect of Sedation on Pulmonary Aeration in Children
Italy180 participantsStarted 2018-02-06
Plain-language summary
Pediatric sedation is an anesthesiological technique with a good safety profile, but various complications might ensure, especially from the respiratory point of view. No suggestion is available about a possible upper safety limit for the duration of sedation to limit respiratory issue. In order to address this topic, the investigators concentrated on the occurrence of hypoventilated lung areas, which is a well-known side effect of anesthesia and sedation. The investigators hypothesis that the length of sedation is correlated with the occurrence of lung atelectasis and hypoventilation. To assess lung hypoventilation the lung ultrasound will be used. Lung ultrasound will be performed immediately after the induction of sedation and immediately before sedation interruption, in children scheduled for magnetic resonance exams.
The study is a prospective observational study
Who can participate
Age range
1 Year – 8 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:
* Children 1-8 years old (included)
* Informed consent of both parents
* Scheduled for elective cerebral or medullary Magnetic Resonance exam
Exclusion Criteria:
* Any ongoing respiratory disease
* Contraindications to the use of propofol
* LUSS ≤12 at the first US assessment (a baseline maximum score 1 on all of the pulmonary fields)
* need for mechanical ventilation
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.
What they're measuring
1
Changes in the Lung Ultrasound Score in children undergoing deep sedation
Timeframe: through study completion, an average of 1 hour