Ultrasound Evaluation of Laryngeal Mask Airway (LMA) Placement in Pediatric Patients and Its Relationship to Postoperative Complications (LMAUSPED)

Valutazione Ultrasonografica Del Corretto Posizionamento Della Maschera Laringea Nel Paziente Pediatrico

This study was designed to improve understanding of some respiratory reactions that can occur after surgery, such as difficulty breathing or persistent cough. These events, technically called PRAE (postoperative respiratory complications), are common reactions in children who have undergone surgery, and our aim is to find out if there are signs that can help us predict them, reducing their incidence in the future.

During surgery, the child will receive general anesthesia, which will put him or her to sleep and not feel pain. In this context, a laryngeal mask airway (LMA) will be used to help the child breathe. The laryngeal mask airway is a soft device that is placed in the throat and allows the airway to be kept open, making breathing possible. This is a standard tool that will be used during surgery regardless of participation in the study.

The aim of this study is to better understand the relationship between the correct positioning of the laryngeal mask airway, measured by a specific ultrasound score, and the frequency of postoperative respiratory events in pediatric patients. As previously stated, these complications are common and well known in pediatric anesthesia practice, and the study aims to explore whether adequate ultrasound assessment can help predict and prevent them in the future. The study aims to observe the position of the laryngeal mask airway through a simple ultrasound and verify whether there is a relationship between the way the mask is positioned and the possibility of postoperative respiratory events. This type of ultrasound is non-invasive and does not add risk to the child.

This ultrasound check will take place without affecting the normal treatment of the patient and does not involve any additional risk or discomfort.

The study is purely observational: this means that we will collect information without modifying in any way the care already foreseen for the child.

The laryngeal mask airway and neck ultrasound are already part of standard medical practice, and the study does not present any additional risks. In this case, it is only a matter of reporting in all children who will participate in the study the "results" of ecological story of the neck (which we will process according to a score) and to evaluate whether there is a relationship between this score and the occurrence of respiratory adverse events upon awakening.

The overall duration of the study is 24 months. In total, we expect to include about 340 patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Paediatric Airway

• Study Type: Observational
• Enrollment (Estimated): 340

Contacts and Locations

• Study Contact: Name: Rachele Simonte; Phone Number: +39 075578 2420; Email: rachele.simonte@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients undergoing surgery under general anesthesia with laryngeal mask airway placement.

Description

Inclusion Criteria:

• Patients undergoing surgery under general anesthesia with laryngeal mask airway placement.

Exclusion Criteria:

• Patients without the need for invasive airway management or undergoing surgery requiring orotracheal intubation.
• Patients with known craniofacial malformations.
• Patients undergoing neck surgery.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation between PRAE incidence and correlation with ultrasound score	The aim of this observational study is to evaluate whether there is a correlation between ultrasonographic data and the incidence of postoperative complications in pediatric patients undergoing general anesthesia for surgery, in order to evaluate the possible predictive power on complications of this diagnostic technique. Postoperative complications or PRAE (Perioperative Respiratory Adverse Events) are: major complications (bronchospasm and laryngospasm) and minor complications (desaturation <95%, signs of airway obstruction with increased effort of accessory respiratory muscles and/or snoring, severe cough for more than 10s continuously, postoperative stridor, presence of blood traces at removal of the LMA)	From enrollment to the discharge from the recovery room

Collaborators and Investigators

• Sponsor: University Of Perugia

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: LMAUSPED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No