Complications of the Alveolar Opening Maneuver in Children on Mechanical Ventilation

NCT07233304 | Recruiting

• 1 other identifier: 080-2025-EO
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Positive End-expiratory Pressure (PEEP); Oxygenation Index; Pediatric Intensive Care Unit; Pediatric Acute Lung Injury; Respiratory Distress Syndrome, Pediatric; Complication

Outcome Measures

Primary Outcomes (1)

• Overall incidence of complications related to the alveolar opening maneuver and PEEP titration

  The number and proportion of patients who develop any adverse event directly associated with the alveolar opening maneuver or PEEP titration within 4 hours after the procedure. Complications may include hemodynamic instability (e.g., hypotension, bradycardia), oxygen desaturation, barotrauma (such as pneumothorax), or cardiac arrhythmias observed during or after the intervention.

  4 hours post-procedure

Study Arms (1)

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.

Procedure: Alveolar Opening Maneuver and PEEP Titration (AOM+P)

Interventions

Alveolar Opening Maneuver and PEEP Titration (AOM+P) PROCEDURE

Standardized ventilatory procedure performed in pediatric patients under invasive mechanical ventilation with acute respiratory distress syndrome (PARDS). The intervention consists of a controlled alveolar opening maneuver with stepwise PEEP increments up to a plateau pressure of 35 cmH₂O (or up to 40 cmH₂O in patients with reduced chest wall compliance), maintained for 2 minutes, followed by a decremental PEEP titration to determine the optimal PEEP level based on driving pressure and oxygenation response. The procedure is performed once clinically indicated, under continuous hemodynamic and oxygen monitoring, according to the institutional safety protocol.

Also known as: Alveolar Opening Protocol, PEEP Titration Procedure, AOM+P Institutional Protocol

Alveolar Opening Maneuver and PEEP Titration (AOM+P)

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All patients under 14 years of age admitted to the Pediatric Intensive Care Unit (PICU) of the Hospital Cuenca Alta Néstor Kirchner

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Alta Complejidad en Red: lead

Study Sites (1)

Hospital Cuenca Alta Néstor Kirchner

Cañuelas, Buenos Aires, B1814, Argentina

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jose Garcia Urrutia, BCS

  Hospital de Alta Complejidad Cuenca Alta "Néstor Kirchner", Buenos Aires, Argentina

  PRINCIPAL INVESTIGATOR

• Belen Castelli, BCS

  Hospital de Alta Complejidad Cuenca Alta "Néstor Kirchner", Buenos Aires, Argentina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Belén B castelli, BCS

CONTACT

+54 2227442582; investigacion@hospitalcuencaalta.org.ar

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)