Complications of the Alveolar Opening Maneuver in Children on Mechanical Ventilation (NCT07233304) | Clinical Trial Compass
RecruitingNot Applicable
Complications of the Alveolar Opening Maneuver in Children on Mechanical Ventilation
Argentina143 participantsStarted 2025-08-18
Plain-language summary
The objective of this research is to analyze the overall incidence of complications associated with a therapeutic maneuver known as alveolar opening and subsequent titration of positive end-expiratory pressure (PEEP) in pediatric patients with acute respiratory distress syndrome (ARDS). These procedures are part of the standard care provided in the Pediatric Intensive Care Unit (PICU) and are used to improve pulmonary oxygenation and respiratory mechanics. Through this study, we aim to gather information that will help improve the safety and effectiveness of these interventions in critically ill patients.
Who can participate
Age range
1 Month – 14 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:
* Patients under 14 years of age admitted to the HCANK PICU
* More than 4 hours of invasive mechanical ventilation (IMV)
* An oxygenation index (OI) ≥4 or an oxygen saturation index (OSI) ≥5
* Indication for ARM and PEEP as determined by the treating team
Exclusion criteria:
* Predicted body weight (PBW) \>45.5 kg
* Recent pulmonary resection surgery (\<7 days)
* Presence of broncho-pleural fistula or peri-tube leak \>25% of the tidal volume
* Hemoglobin decline \<7 g/dL
* Patients with congenital or acquired heart diseases with significant intracardiac shunt.
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
Overall incidence of complications related to the alveolar opening maneuver and PEEP titration