Actively Recruiting
Incidence of Complications From the Alveolar Opening Maneuver in Mechanically Ventilated Children With Respiratory Distress Syndrome
Led by Hospital de Alta Complejidad en Red · Updated on 2025-11-18
143
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research analyzes the frequency of complications related to a therapeutic procedure called the alveolar opening maneuver combined with positive end-expiratory pressure (PEEP) in children with acute respiratory distress syndrome (ARDS) who are in the Pediatric Intensive Care Unit (PICU). These interventions, part of standard care, aim to improve lung oxygenation and breathing mechanics in critically ill pediatric patients. The study is observational and will provide important safety information about these common treatments. The study involves pediatric patients under 14 years old who are on invasive mechanical ventilation for more than four hours and meet certain oxygenation criteria. The procedure includes carefully raising PEEP to specific pressure levels, maintaining it briefly, then lowering it to find the best setting based on lung pressures and oxygen levels. This maneuver is performed once when medically needed, guided by the treating team and following a set safety protocol with continuous monitoring. Participants will have baseline clinical data recorded before the procedure and monitored closely during and for four hours afterward to detect any complications. If repeated, monitoring continues for four hours after the last maneuver. Researchers will collect demographic and clinical information and analyze the overall rate of complications using statistical methods. The study will continue until 143 procedures have been observed, contributing data to improve care in ventilated children with ARDS.
CONDITIONS
Brief Title
Complications of the Alveolar Opening Maneuver in Children on Mechanical Ventilation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients under 14 years of age admitted to the HCANK PICU
- More than 4 hours of invasive mechanical ventilation (IMV)
- An oxygenation index (OI) of 4 or higher or an oxygen saturation index (OSI) of 5 or higher
- Indication for alveolar opening maneuver and PEEP as determined by the treating team
You will not qualify if you...
- Predicted body weight greater than 45.5 kg
- Pulmonary resection surgery within the last 7 days
- Presence of broncho-pleural fistula or peri-tube leak exceeding 25% of tidal volume
- Hemoglobin levels below 7 g/dL
- Congenital or acquired heart diseases with significant intracardiac shunt
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure performed once when clinically indicated plus 4 hours of post-procedure monitoring
Participants undergo a standardized alveolar opening maneuver and PEEP titration procedure as part of their routine care, with continuous hemodynamic and oxygen monitoring during the procedure.
1 procedure session followed by 4 hours of observation
Trial Site Locations
Total: 1 location
1
Hospital Cuenca Alta Néstor Kirchner
Canuelas, Buenos Aires, Argentina, B1814
Actively Recruiting
Research Team
M
Maria Belén B castelli, BCS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here