Pulmonary Ultrasound for the Assessment of Atelectasis in Anesthetized Children Using a Laryngeal Mask Airway.

Completed

• Conditions: Hypoxemia; Atelectasis
• Interventions: Diagnostic Test: Lung Ultrasounds

• Registration Number: NCT06214312
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief Summary

This study will use lung ultrasounds (LUS) to evaluate the incidence and severity of intraoperative atelectasis in anesthetized children undergoing minor surgery using a laryngeal mask airway. The children will be randomly assigned to be left in spontaneous ventilation with a Positive End Expiratory Pressure (PEEP) of 5cmH2O or to be ventilated with a pressure support mode.

Detailed Description

It is well known and described the deleterious effect that general anesthesia (GA) has on functional residual capacity (FRC), especially in children. This population is at higher risk of decreasing FRC during GA because of their lower capacity for elastic retraction and lower relaxation volume comparing to adults, predisposing them to the development of atelectasis and airway closure. These factors will lead to intrapulmonary shunts, which may impair the gas exchange and consequently oxygenation. By reducing the intrapulmonary shunt, Positive End Expiratory Pressure (PEEP) during controlled mechanical ventilation in patients with healthy lungs optimizes the FRC. However, the available data for an optimal ventilation strategy, including optimal PEEP, using a laryngeal mask airway (LMA) in the pediatric population are scarce, even though this device is frequently used in all age groups for brief general anesthesia.

Diagnosing anesthesia-induced atelectasis in the perioperative period can be possible by using lung ultrasounds (LUS), a simple, easily accessible, non-invasive and radiation free technique, which might help determine the impact in pulmonary aeration between different ventilation strategies. In our study, we will focus on comparing spontaneous ventilation (VS) with a PEEP of 5 cmH2O and pressure-support ventilation using a LMA in anesthetized children undergoing minor and elective outpatient surgery.

Study Timeline

• Study First Submitted: 2023-12-04
• Status Verified: 2024-01
• Study Start: 2024-01-15
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-19
• Primary Completion: 2024-04-30
• Study Completion: 2024-06-23
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

Inclusion Criteria

• fasted children between 12 months and 8 years of age; American Society of Anesthesiology (ASA) score I or II without lung disease; baseline pulse oximetry in room air >96%; scheduled for minor urological surgery (circumcision) under general anesthesia; written parent's agreement.

Exclusion Criteria

• ASA score > II, chronic lung disease, airway infection in the last 15 days, impossibility of insertion of LMA.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spontaneous ventilation	Lung Ultrasounds	Anesthetized Children ventilated with a laryngeal mask airway in spontaneous ventilation with a positive end expiratory pressure of 5cmH2O.
Pressure support ventilation	Lung Ultrasounds	Anesthetized Children ventilated with a laryngeal mask airway in pressure support ventilation with a positive end expiratory pressure of 5cmH2O, maximum pressure not exceeding 15cmH2O.

Primary Outcome Measures

Name	Time	Method
Pulmonary aeration	during surgery and in the immediate postoperative period	Compare the Lung Aeration Score in the two groups

Secondary Outcome Measures

Name	Time	Method
Ventilatory parameters	during surgery	Correlation between Lung Aeration Score and Ventilatory parameters
Plethysmography	during surgery and in the immediate postoperative period.	Correlation between Lung Aeration Score and Plethysmography

Trial Locations

Locations (1)

Chu St. Pierre; 🇧🇪 Brussel, Brussels, Belgium