RecruitingNCT07233304

Complications of the Alveolar Opening Maneuver in Children on Mechanical Ventilation

Incidence of Complications From the Alveolar Opening Maneuver in Mechanically Ventilated Children With Respiratory Distress Syndrome

Sponsor

Hospital de Alta Complejidad en Red

Enrollment

143 participants

Start Date

Aug 18, 2025

Study Type

OBSERVATIONAL

Conditions

Complication Positive End-expiratory Pressure (PEEP)Oxygenation Index Respiratory Distress Syndrome, Pediatric Pediatric Intensive Care Unit Pediatric Acute Lung Injury

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

Min Age: 1 MonthMax Age: 14 Years

Inclusion Criteria4

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 Criteria5

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.

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Interventions

PROCEDUREAlveolar Opening Maneuver and PEEP Titration (AOM+P)

Standardized ventilatory procedure performed in pediatric patients under invasive mechanical ventilation with acute respiratory distress syndrome (PARDS). The intervention consists of a controlled alveolar opening maneuver with stepwise PEEP increments up to a plateau pressure of 35 cmH₂O (or up to 40 cmH₂O in patients with reduced chest wall compliance), maintained for 2 minutes, followed by a decremental PEEP titration to determine the optimal PEEP level based on driving pressure and oxygenation response. The procedure is performed once clinically indicated, under continuous hemodynamic and oxygen monitoring, according to the institutional safety protocol.