Laryngeal Mask Position in Magnetic Resonance Imaging in Children

NCT ID: NCT02940652

Last Updated: 2018-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-05-31

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.

Conditions

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Laryngeal Mask Malposition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Paediatric patients undergoing MRI scanning

All paediatric patients undergoing elective MRI scanning of the brain and/or brain and cervical spine

Magnetic resonance imaging

Intervention Type RADIATION

No intervention - description of the position of the LMA obtained during routine elective MRI scanning of the brain and/or cervical spine

Interventions

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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

Intervention Type RADIATION

Other Intervention Names

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MRI

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
Minimum Eligible Age

28 Days

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brno University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Petr Štourač, MD

doc.MD.Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Petr Štourač, doc.MD.Ph.D

Role: STUDY_DIRECTOR

University Hospital Brno

Locations

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University Hospital Brno

Brno, Jihomoravský Kraj, Czech Republic, Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type DERIVED
PMID: 30355285 (View on PubMed)

Related Links

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Other Identifiers

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KDAR FN Brno 2016

Identifier Type: -

Identifier Source: org_study_id

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