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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: investigacion@hospitalcuencaalta.org.ar
• Phone: +54 2227442582

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.