Laryngeal Mask Position in Magnetic Resonance Imaging in Children

Study Overview
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Brief Summary
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The aim of the trial is to obtain and to describe the position of the laryngeal mask during elective magnetic resonance imaging in paediatric patient. The radiologic findings will be compared to the clinical performance of the laryngeal mask.

Detailed Description
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Properly inserted laryngeal mask (LMA) with good clinical performance can be misplaced (on radiological imaging) but with not know effect on clinical practice. The percentage of the misplaced LMAs are relatively high, but the exact number in paediatric population is currently not clear. The aim of this prospective observational cohort study is to describe the percentage of misplaced LMAs during elective magnetic resonance imaging (MRI) in paediatric patient. After approval of the local ethical committee all elective paediatric patients in study interval (10/2016-3/2017) indicated for elective MRI of the brain or elective MRI of the brain and cervical spine will be included to the trial. Demographic characteristics - age, weight, comorbidities, anesthesia management - education of anesthesiologist, type of LMA, number of insertion attempts, clinical performance of the LMA, presence/absence of leak, the peak inspiratory pressure (mechanical ventilation), volume of air in cuff, complications during anesthesia and LMA soil after extraction - blood, saliva, mucus, gastric content. The clinical performance will be compared to the LMA position on MRI - position of the proximal and the distal site of the LMA cuff according to the cervical vertebrae, displacement of the epiglottis, distance between proximal LMA cuff and vocal cords, distance between distal LMA cuff and vocal cords.

Official Title
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Position of Laryngeal Mask in Paediatric Patients During Magnetic Resonance Imaging: Prospective Observational Cohort Study

Conditions
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Laryngeal Mask Malposition

Intervention / Treatment
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* Radiation: Magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: paediatric patient undergoing elective MRI scanning - brain and/or brain and cervical spine laryngeal mask inserted for airway management during anesthesia age between 29 days and 19 years Exclusion Criteria: outside the age limit laryngeal mask contraindication - gastroesophageal reflux disease, ileus, full stomach, impairment of the haemodynamics

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paediatric patients undergoing MRI scanning<br>All paediatric patients undergoing elective MRI scanning of the brain and/or brain and cervical spine | Radiation: Magnetic resonance imaging<br>* No intervention - description of the position of the LMA obtained during routine elective MRI scanning of the brain and/or cervical spine<br>* Other names: MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Displacement of the laryngeal mask on the MRI imaging | position of the proximal and the distal site of the LMA cuff according to the cervical vertebrae distance between proximal LMA cuff and vocal cords | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance of the LMA | complications associated with airway management | 6 months | 
| Demographic characteristics | age, weight, comorbidities | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngeal mask,MRI