Acute Respiratory Distress Syndrome (ARDS) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 14
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Argentina
Hospital Cuenca Alta Néstor Kirchner
RECRUITING
Canuelas
Contact Information
Primary
Maria Belén B castelli, BCS
investigacion@hospitalcuencaalta.org.ar
+54 2227442582
Time Frame
Start Date: 2025-08-18
Estimated Completion Date: 2026-08
Participants
Target number of participants: 143
Treatments
Alveolar Opening Maneuver and PEEP Titration (AOM+P)
Patients under invasive mechanical ventilation for pediatric acute respiratory distress syndrome (PARDS) who undergo a standardized alveolar opening maneuver followed by decremental PEEP titration according to institutional protocol. The maneuver consists of stepwise increases in PEEP until reaching a plateau pressure of 35 cmH₂O (or up to 40 cmH₂O in patients with reduced chest wall compliance), maintained for 2 minutes, followed by decremental PEEP titration to determine the optimal level based on driving pressure and oxygen saturation. The procedure is performed once clinically indicated, with continuous hemodynamic and oxygenation monitoring.
Sponsors
Leads: Hospital de Alta Complejidad en Red

This content was sourced from clinicaltrials.gov