Clinical trial NCT02940652: Laryngeal Mask Position in Magnetic Resonance Imaging in Children
Official title: Position of Laryngeal Mask in Paediatric Patients During Magnetic Resonance Imaging: Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngeal Mask Malposition
Keywords: Laryngeal mask,MRI
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 220
Sex: ALL
Minimum age (years): 28
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paediatric patients undergoing elective magnetic resonance imaging of the head (brain) and/or head (brain) and cervical spine

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.

Eligibility criteria: 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

Primary outcomes:
measure: Displacement of the laryngeal mask on the MRI imaging
timeFrame: 6 months
Secondary outcomes:
measure: Clinical performance of the LMA
timeFrame: 6 months
measure: Demographic characteristics
timeFrame: 6 months
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
state: Jihomoravský Kraj, Czech Republic
Study officials:
affiliation: University Hospital Brno
name: Petr Štourač, doc.MD.Ph.D
role: STUDY_DIRECTOR
References:
citation: Klucka J, Senkyrik J, Skotakova J, Stoudek R, Toukalkova M, Krikava I, Marecek L, Pavlik T, Stouracova A, Stourac P. Laryngeal mask airway Unique position in paediatric patients undergoing magnetic resonance imaging (MRI): prospective observational study. BMC Anesthesiol. 2018 Oct 24;18(1):153. doi: 10.1186/s12871-018-0617-2.