NCT07233304 Complications of the Alveolar Opening Maneuver in Children on Mechanical Ventilation
| NCT ID | NCT07233304 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital de Alta Complejidad en Red |
| Condition | Positive End-expiratory Pressure (PEEP) |
| Study Type | OBSERVATIONAL |
| Enrollment | 143 participants |
| Start Date | 2025-08-18 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 143 participants in total. It began in 2025-08-18 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Jose Garcia Urrutia, BCS
PRINCIPAL INVESTIGATOR
Hospital de Alta Complejidad Cuenca Alta "Néstor Kirchner", Buenos Aires, Argentina
Frequently Asked Questions
Who can join the NCT07233304 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 14 Years, studying Positive End-expiratory Pressure (PEEP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07233304 currently recruiting?
Yes, NCT07233304 is actively recruiting participants. Contact the research team at investigacion@hospitalcuencaalta.org.ar for enrollment information.
Where is the NCT07233304 trial being conducted?
This trial is being conducted at Canuelas, Argentina.
Who is sponsoring the NCT07233304 clinical trial?
NCT07233304 is sponsored by Hospital de Alta Complejidad en Red. The principal investigator is Jose Garcia Urrutia, BCS at Hospital de Alta Complejidad Cuenca Alta "Néstor Kirchner", Buenos Aires, Argentina. The trial plans to enroll 143 participants.