Laryngeal Mask Position in Magnetic Resonance Imaging in Children

Completed

• Conditions: Laryngeal Mask Malposition
• Interventions: Radiation: Magnetic resonance imaging

• Registration Number: NCT02940652
• Lead Sponsor: Brno University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-21
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Paediatric patients undergoing MRI scanning	Magnetic resonance imaging	All paediatric patients undergoing elective MRI scanning of the brain and/or brain and cervical spine

Primary Outcome Measures

Name	Time	Method
Displacement of the laryngeal mask on the MRI imaging	6 months	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

Secondary Outcome Measures

Name	Time	Method
Clinical performance of the LMA	6 months	complications associated with airway management
Demographic characteristics	6 months	age, weight, comorbidities

Trial Locations

Locations (1)

University Hospital Brno; 🇨🇿 Brno, Jihomoravský Kraj, Czech Republic, Czechia