Respiratory Muscles and Work of Breathing in Children

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

RECRUITING

Clinical Phase

NA

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-19

Study Completion Date

2028-01-31

Brief Summary

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Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management.

The primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.

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Detailed Description

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Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management.

Respiratory muscle testing by means of esogastric measurements may allow assessing the effect of pharmacological treatment by comparing respiratory muscle strength before and after a few months with treatment. Moreover, esogastric measurements can be used to better adapt mechanical ventilation or to determine the possibility of weaning from the respiratory support.

The primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.

Conditions

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Neuromuscular Diseases Congenital Diaphragmatic Hernia Lung Diseases Cardiac Diseases Scoliosis Diaphragmatic Impairment Respiratory Muscle Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Respiratory muscle impairment

Minor patients with primary or secondary impairment of respiratory muscles and followed at Necker Hospital

Group Type EXPERIMENTAL

Esogastric pressure measurement

Intervention Type OTHER

Measurement of work of breathing and respiratory muscles strength using an esogastric catheter.

One measurement or before and after (6 months and 1 year) the initiation of a pharmacological treatment in order to assess the effect of the treatment on respiratory muscle function.

Interventions

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Esogastric pressure measurement

Measurement of work of breathing and respiratory muscles strength using an esogastric catheter.

One measurement or before and after (6 months and 1 year) the initiation of a pharmacological treatment in order to assess the effect of the treatment on respiratory muscle function.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged less than 18 years old with primary or secondary impairment of respiratory muscles and followed at Necker Hospital
* Patients under spontaneous breathing or noninvasive or invasive mechanical ventilation
* Written informed consent

Exclusion Criteria

* No social insurance
* Significant psychomotor retardation
* Absence of cooperation
* Significant agitation
* Hemodynamic instability
* Acute condition or temporary drug treatments that may interfere with the results of the respiratory muscle explorations

Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No