Laryngeal Mask Position in Magnetic Resonance Imaging in Children (LPIMRICH)

November 16, 2018 updated by: Petr Štourač, MD, Brno University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Jihomoravský Kraj, Czech Republic
      • Brno, Jihomoravský Kraj, Czech Republic, Czechia, 62500
        • University Hospital Brno

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Paediatric patients undergoing MRI scanning
All paediatric patients undergoing elective MRI scanning of the brain and/or brain and cervical spine
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
Other Names:
  • MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Displacement of the laryngeal mask on the MRI imaging
Time Frame: 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
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brno University Hospital

Investigators

  • Study Director: Petr Štourač, doc.MD.Ph.D, University Hospital Brno

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KDAR FN Brno 2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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