Actively Recruiting

Age: 1Month - 14Years
All Genders
ID07233304

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

Age: 1Month - 14Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Loading map...

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

Evaluation of Altitude as an Independent Risk Factor for Mor...

Respiratory Distress Syndrome, Pediatric

Actively Recruiting

20 locations

Assessment of Women's Sexual Quality of Life After Benign Ad...

Gynecologic Disease

Actively Recruiting

1 location

The Effect of a Kolcaba Comfort Theory-Based Child Comfort I...

Pediatric Intensive Care Unit

Actively Recruiting

1 location

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