Clinical trial NCT05051254: Respiratory Muscles and Work of Breathing in Children
Official title: Respiratory Muscles and Work of Breathing in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromuscular Diseases
Congenital Diaphragmatic Hernia
Lung Diseases
Cardiac Diseases
Scoliosis
Diaphragmatic Impairment
Respiratory Muscle Impairment
Keywords: Respiratory muscle testing
Respiratory muscle strength
Work of breathing
Esogastric pressures
Diaphragmatic dysfunction
Diaphragmatic paralysis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 550
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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

Primary outcomes:
measure: Esophageal pressure-time product (PTPoes)
timeFrame: Day 0
measure: Diaphragmatic pressure-time product (PTPdi)
timeFrame: Day 0
measure: Work of breathing (WOB)
timeFrame: Day 0
Secondary outcomes:
measure: Vital capacity
timeFrame: Day 0
measure: Maximal respiratory static pressures
timeFrame: Day 0
measure: Maximal sniff pressure
timeFrame: Day 0
measure: Maximal whistle pressure
timeFrame: Day 0
measure: Peak expiratory flow
timeFrame: Day 0
measure: Peak cough flow
timeFrame: Day 0
measure: Esophageal pressure during sniff
timeFrame: Day 0
measure: Gastric pressure during sniff
timeFrame: Day 0
measure: Transdiaphragmatic pressure during sniff
timeFrame: Day 0
measure: Crying transdiaphragmatic pressure
timeFrame: Day 0
measure: Gastric pressure during cough
timeFrame: Day 0
measure: Twitch transdiaphragmatic pressure
timeFrame: Day 0
measure: Inspiratory muscles tension-time index
timeFrame: Day 0
measure: Diaphragmatic tension-time index
timeFrame: Day 0
measure: Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with the disease severity
timeFrame: Day 0
measure: Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with polysomnography and gas exchange results
timeFrame: Day 0
measure: Esophageal pressure-time products in patients with any treatment and in patients with no treatment
timeFrame: Day 0
measure: The total work of breathing in patients with any treatment and in patients with no treatment
timeFrame: Day 0
measure: Measurement of esophageal pressure during a sniff in patients with any treatment and patients with no treatment
timeFrame: Day 0
measure: Measurement of the esophageal pressure-time product before and after pharmacological treatment
timeFrame: 6 months and 1 year after treatment initiation
measure: The total work of breathing before and after pharmacological treatment
timeFrame: 6 months and 1 year after treatment initiation
measure: Measurement of the esophageal pressure during a sniff before and after pharmacological treatment
timeFrame: 6 months and 1 year after treatment initiation
measure: Measurement of transdiaphragmatic pressure during a sniff before and after pharmacological treatment
timeFrame: 6 months and 1 year after treatment initiation
measure: Adaptation of the respiratory support according to the esophageal pressure-time product values
timeFrame: Day 0
measure: Adaptation of the respiratory support according to the total work of breathing values
timeFrame: Day 0
measure: Measurement of the esophageal pressure-time product in patients with weaning success and in patients with weaning failure
timeFrame: Day 0
measure: Measurement of the total work of breathing in patients with weaning success and in patients with weaning failure
timeFrame: Day 0
measure: Measurement of the esophageal pressure during a sniff in patients with weaning success and in patients with weaning failure
timeFrame: Day 0
measure: Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with the gas exchange during weaning trial
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Brigitte FAUROUX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sonia KHIRANI, PhD
role: STUDY_DIRECTOR
References: