Clinical trial NCT06712732: Ultrasound Evaluation of Laryngeal Mask Airway (LMA) Placement in Pediatric Patients and Its Relationship to Postoperative Complications
Official title: Valutazione Ultrasonografica Del Corretto Posizionamento Della Maschera Laringea Nel Paziente Pediatrico
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Paediatric Airway
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 340
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients undergoing surgery under general anesthesia with laryngeal mask airway placement.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation between PRAE incidence and correlation with ultrasound score
timeFrame: From enrollment to the discharge from the recovery room
Secondary outcomes:
Other outcomes:
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Study officials:
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