Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia (NCT05737407) | Clinical Trial Compass
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Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia
Italy280 participantsStarted 2023-03-01
Plain-language summary
The goal of this RCT is to demonstrate that, in neonatal anesthesia, the use of Lung Ultrasound (LUS) to guide choice of best Positive End-Expiratory Pressure (Peep) - the one that efficiently avoids lung atelectasis - leads to better gas exchange in the lung thus can lead to reduction of FiO2 applied to ventilatory setting in order to achieve same peripheral saturations of oxygen (SpO2).
Specific aims of the study are:
1. to determine if LUS-guided PEEP choice in neonatal anesthesia, compared to standard PEEP choice, can lead to reduction of FiO2 applied to the ventilatory setting in order to maintain same SpO2s.
2. to determine if patients treated with LUS-guided PEEP will develop less postoperative pulmonary complications in the first 24 hours.
3. to compare static respiratory system compliance between groups.
4. to determine if there is a significant difference in hemodynamic parameters and amount of fluids infused or need for vasopressors between the two groups.
Who can participate
Age range
33 Weeks – 50 Weeks
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:
* patients born after 33 weeks of gestationand up to the age of 50 post-conceptional weeks undergoing elective or urgent surgery requiring general anesthesia with endotracheal intubation
Exclusion Criteria:
* born at less than 33 weeks of gestation
* patients with signs or symptoms of cardiac or lung abnormalities or diseases
* patients with suspected/confirmed immune diseases, known or suspected metabolic or genetic conditions
* no parental consent is obtained
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
Change of FiO2 applied to the ventilatory setting in order to maintain same SpO2s.