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Complications of the Alveolar Opening Maneuver in Children on Mechanical Ventilation

NCT07233304 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 143

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Alveolar 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.

Sponsors & Collaborators

  • Hospital de Alta Complejidad en Red

    lead OTHER

Principal Investigators

  • Jose Garcia Urrutia, BCS · Hospital de Alta Complejidad Cuenca Alta "Néstor Kirchner", Buenos Aires, Argentina

  • Belen Castelli, BCS · Hospital de Alta Complejidad Cuenca Alta "Néstor Kirchner", Buenos Aires, Argentina

Eligibility

Min Age
1 Month
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07233304 on ClinicalTrials.gov