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Recruiting NCT05051254

Respiratory Muscles and Work of Breathing in Children

No phase Interventional Neuromuscular Diseases Congenital Diaphragmatic Hernia Lung Diseases Cardiac Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Esogastric pressure measurement.
Who it may be relevant to
Registry conditions: Neuromuscular Diseases, Congenital Diaphragmatic Hernia, Lung Diseases, Cardiac Diseases. Basic parameters: 0 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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.

Interventions

  • Other 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.

Primary outcome measures

  • Esophageal pressure-time product (PTPoes) [Time frame: Day 0]
  • Diaphragmatic pressure-time product (PTPdi) [Time frame: Day 0]
  • Work of breathing (WOB) [Time frame: Day 0]
Secondary outcome measures (12)
  • Vital capacity [Time frame: Day 0]
  • Maximal respiratory static pressures [Time frame: Day 0]
  • Maximal sniff pressure [Time frame: Day 0]
  • Maximal whistle pressure [Time frame: Day 0]
  • Peak expiratory flow [Time frame: Day 0]
  • Peak cough flow [Time frame: Day 0]
  • Esophageal pressure during sniff [Time frame: Day 0]
  • Gastric pressure during sniff [Time frame: Day 0]
  • Transdiaphragmatic pressure during sniff [Time frame: Day 0]
  • Crying transdiaphragmatic pressure [Time frame: Day 0]
  • Gastric pressure during cough [Time frame: Day 0]
  • Twitch transdiaphragmatic pressure [Time frame: Day 0]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Hôpital Necker-Enfants Malades — Paris

Identifiers

NCT: NCT05051254 · APHP210261 · ID-RCB 2020-A03393-36

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗