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 range1 Month – 14 Years

SexALL

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.

What they're measuring

Overall incidence of complications related to the alveolar opening maneuver and PEEP titration

Timeframe: 4 hours post-procedure

Trial details

NCT IDNCT07233304

SponsorHospital de Alta Complejidad en Red

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08

Contact for this trial

Maria Belén B castelli, BCS

+54 2227442582 investigacion@hospitalcuencaalta.org.ar