Age Influence on the Modifications of the Oral, Pharyngeal and Laryngeal Axis Alignment in Children Induced by Head Extension: an MRI Study

February 24, 2014 updated by: Assistance Publique Hopitaux De Marseille

In pediatric anesthesia and in pediatric intensive care, tracheal intubation is one of the most important procedure. To achieve this procedure as fast as possible and in is best conditions, the physician should choose the head posture which a priori will enable at first the best glottic visualisation during laryngoscopy, and at second will facilitate the route of the tube from the larynx to the trachea.

Tracheal intubation is a procedure used for years, and many textbooks recommendations on the best head posture for tracheal intubation in paediatrics have been made. Briefly summarized, depending on the age of the child, the head should (or not) be slightly extended, and a pillow should (or not) be positioned under the occiput. These recommendations are questionable for three majors reasons:

  • despite an apparent consensus, some recommendations are quite different.
  • none are based on anatomical nor clinical studies
  • if for all of them, the age of the child is considered as critical point, but children are only grossly categorized in three categories (newborn, infants and old children). And the clinician has no way, facing a child, to make his choice between dichotomic attitudes.

Actually, the responses to these questions should need rigourous clinical studies on laryngoscopy, hard to design and very difficult to make. P.Adnet et coll. (Anesthesiology 2001) showed that an anatomical study with resonance magnetic imaging (MRI) can bring indirect but strong evidence and can be a first step leading to clinical studies. Many children need MRI study for different reasons, and it is fast and easy to get during their examination additional images of the superior airway.

In their unit, the investigators are experienced in this kind of study, as they recently published (Pediatric Anesthesia 2008) an MRI study demonstrating that in children, head extension improves the alignment of the visualisation axis on the laryngeal axis, but worsens the alignment of the pharyngeal axis on the laryngeal axis. However, patients included in their study were in major part infants, so the influence of the age could not be properly analyzed. Morevover, this study suffered of two main limitations, the lack of standardisation of head postures, and that a laryngeal mask the children, who were on general anesthesia (required for the MRI examination) were made using a laryngeal mask (as it was at this time the standard in their institution).

The investigators propose an MRI study of the influence of age on the consequences of head extension on the anatomic axes of the superior airway in children, with a prospective stratified on age study. Several modifications and improvement in the design of this study would diminished the limitations of the first study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

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

  • France
      • Marseille, France
        • Assistance Publique - Hopitaux de Marseille
      • Marseille, France
        • Assistance Publique-Hôpitaux de Marseille

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

9 months to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No obesity
  • No macro- or micro-cephaly
  • No facial dysmorphism
  • No tumor near to the superior airway

Exclusion Criteria:

  • Premature child
  • MRI in emergency
  • Discovery of a tumor near to the superior airway during the MRI

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

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To study the influence of age on the consequences of head extension on the anatomic axes of the superior airway in children
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Renaud Vialet, Assistance Publique - Hopitaux de Marseille

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

May 1, 2009

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 12, 2009

First Posted (ESTIMATE)

June 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2009/06
  • 2009-A00163-54

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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