Respiratory Muscles and Work of Breathing in Children (WOB&MR_Ped)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Diaphragmatic Impairment; Lung Diseases; Neuromuscular Diseases; Respiratory Muscle Impairment; Cardiac Diseases; Scoliosis; Congenital Diaphragmatic Hernia

Treatments: Other: Esogastric pressure measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT05051254

ID-RCB 2020-A03393-36 (Other Identifier)

APHP210261

Details and patient eligibility

About

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.

Full 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.

Enrollment: 550 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

550 participants in 1 patient group

Respiratory muscle impairment

Experimental group

Description:

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

Treatment:

Other: Esogastric pressure measurement