Risks of lung-opening maneuvers and PEEP adjustments in ventilated children

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

This project will track how often lung-opening maneuvers and PEEP adjustments cause complications in children under 14 who are on mechanical ventilation in the PICU.

Quick facts

• Study type: Observational
• Enrollment: 143 (estimated)
• Ages: 1 Month to 14 Years
• Sex: All
• Sponsor: Hospital de Alta Complejidad en Red (other)
• Locations: 1 site (Canuelas, Buenos Aires)
• Trial ID: NCT07233304 on ClinicalTrials.gov

What this trial studies

This is a prospective cohort study conducted in the Pediatric Intensive Care Unit at Hospital Cuenca Alta Néstor Kirchner between April and September, where clinicians will record complications occurring during routine alveolar opening maneuvers and subsequent PEEP titration. All eligible patients under 14 years on invasive mechanical ventilation with an oxygenation index (OI) ≥4 or oxygen saturation index (OSI) ≥5 who undergo these interventions as part of standard care will be included, with an expected analysis of about 143 maneuvers. Demographic and clinical variables will be collected and the primary outcome is the overall incidence of complications related to the maneuver and PEEP adjustments. The study follows established institutional protocols and exclusion criteria to protect patients with recent lung surgery, large leaks, significant shunts, severe anemia, or excessive body weight.

Who should consider this trial

Good fit: Children younger than 14 admitted to the HCANK PICU who have been on invasive mechanical ventilation for more than 4 hours and have OI ≥4 or OSI ≥5 with a treating-team indication for alveolar opening maneuvers and PEEP titration are ideal candidates.

Not a fit: Patients with predicted body weight over 45.5 kg, recent pulmonary resection (<7 days), broncho-pleural fistula or large peri-tube leak (>25% tidal volume), hemoglobin <7 g/dL, or significant intracardiac shunt are excluded and unlikely to benefit from this protocol’s results.

Why it matters

Potential benefit: If successful, the findings could clarify how often these maneuvers cause harm and help refine local protocols to make lung recruitment and PEEP titration safer for critically ill children.

How similar studies have performed: Similar recruitment maneuvers and PEEP strategies have been studied in adults and in limited pediatric series with mixed efficacy and recognized safety concerns, so pediatric-specific prospective complication data remain relatively limited.

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.

Where this trial is running

Canuelas, Buenos Aires

• Hospital Cuenca Alta Néstor Kirchner — Canuelas, Buenos Aires, Argentina (RECRUITING)

Study contacts

• Principal investigator: Jose Garcia Urrutia, BCS — Hospital de Alta Complejidad Cuenca Alta "Néstor Kirchner", Buenos Aires, Argentina
• Study coordinator: Maria Belén B castelli, BCS

Conditions: Positive End-expiratory Pressure, Oxygenation Index, Pediatric Intensive Care Unit, Pediatric Acute Lung Injury, Respiratory Distress Syndrome, Pediatric, Complication