Laryngeal Mask Position in Magnetic Resonance Imaging in Children

Laryngeal Mask Malposition Clinical Trial

— LPIMRICH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02940652
• Other study ID #: KDAR FN Brno 2016
• Status: Completed
• Start date: October 2016
• Est. completion date: May 2017

Study information

• Verified date: November 2018
• Source: Brno University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Laryngeal Mask Malposition

Intervention

Radiation:
• Magnetic resonance imaging
No intervention - description of the position of the LMA obtained during routine elective MRI scanning of the brain and/or cervical spine

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno	Jihomoravský Kraj, Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical performance of the LMA	complications associated with airway management	6 months
Secondary	Demographic characteristics	age, weight, comorbidities	6 months

External Links

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