Respiratory Muscles and Work of Breathing in Children

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-17
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

No social insurance

Significant psychomotor retardation

Absence of cooperation

Significant agitation

Trial design

Design model

Single group

Treatments tested in this trial

  • Esogastric pressure measurement

    Other intervention

    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.

Treatment groups

550 Participants
are divided into 1 treatment group
Group A: Respiratory muscle impairmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Esophageal pressure-time product (PTPoes)

The integral of the esophageal pressure signal over inspiratory time

Time frame
Day 0
2

Diaphragmatic pressure-time product (PTPdi)

The integral of the transdiaphragmatic pressure signal over inspiratory time

Time frame
Day 0
3

Work of breathing (WOB)

Total work of breathing (WOBt) is calculated (in Joules/L) as the area under the pressure-volume curve, using the Campbell diagram. Elastic (WOBe) and resistive (WOBr) are estimated as the 2/3 and 1/3 of WOBt value, respectively.

Time frame
Day 0

Secondary outcomes

1

Vital capacity

Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation, using spirometry

Time frame
Day 0
2

Maximal respiratory static pressures

Maximal static inspiratory and expiratory airway pressures

Time frame
Day 0
3

Maximal sniff pressure

Airway pressure during a sniff test

Time frame
Day 0
4

Maximal whistle pressure

Airway pressure during a whistle test

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator