Complications of the Alveolar Opening Maneuver in Children on Mechanical Ventilation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-14
SponsorHospital de Alta Complejidad en Red

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

All patients under 14 years of age admitted to the Pediatric Intensive Care Unit (PICU) of the Hospital Cuenca Alta Néstor Kirchner

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Alveolar Opening Maneuver and PEEP Titration (AOM+P)

    Procedure/Surgery

    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.

Treatment groups

143 Participants
are divided into 1 treatment group
Group A: Alveolar Opening Maneuver and PEEP Titration (AOM+P)1 intervention

Trial outcomes

Primary outcomes

1

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

The number and proportion of patients who develop any adverse event directly associated with the alveolar opening maneuver or PEEP titration within 4 hours after the procedure. Complications may include hemodynamic instability (e.g., hypotension, bradycardia), oxygen desaturation, barotrauma (such as pneumothorax), or cardiac arrhythmias observed during or after the intervention.

Time frame
4 hours post-procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

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