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NCT Number: NCT05051254

Respiratory Muscles and Work of Breathing in Children

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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Key information

Conditions

Neuromuscular Diseases Bone Diseases Cardiac Diseases Cardiovascular Diseases Congenital Abnormalities Congenital Diaphragmatic Hernia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diaphragmatic Impairment Heart Diseases Hernia Hernia, Diaphragmatic Hernias, Diaphragmatic, Congenital Internal Hernia Lung Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Muscle Impairment Respiratory Paralysis Respiratory Tract Diseases Scoliosis Signs and Symptoms Spinal Curvatures Spinal Diseases

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location status: Recruiting

Location contact

Brigitte FAUROUX, MD, PhD

CONTACT

[email protected]

1 71 19 60 92 ext. +33

Lucie GRIFFON, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esogastric pressure measurement

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.

Primary outcomes

  1. Esophageal pressure-time product (PTPoes)

    Time frame: Day 0

    The integral of the esophageal pressure signal over inspiratory time

  2. Diaphragmatic pressure-time product (PTPdi)

    Time frame: Day 0

    The integral of the transdiaphragmatic pressure signal over inspiratory time

  3. Work of breathing (WOB)

    Time frame: Day 0

    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.

Secondary outcomes

  1. Vital capacity

    Time frame: Day 0

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

  2. Maximal respiratory static pressures

    Time frame: Day 0

    Maximal static inspiratory and expiratory airway pressures

  3. Maximal sniff pressure

    Time frame: Day 0

    Airway pressure during a sniff test

  4. Maximal whistle pressure

    Time frame: Day 0

    Airway pressure during a whistle test

  5. Peak expiratory flow

    Time frame: Day 0

    Maximal flow during expiratory maneuver

  6. Peak cough flow

    Time frame: Day 0

    Maximal flow during cough

  7. Esophageal pressure during sniff

    Time frame: Day 0

    Esophageal pressure measurement during a sniff test

  8. Gastric pressure during sniff

    Time frame: Day 0

    Gastric pressure measurement during a sniff test

  9. Transdiaphragmatic pressure during sniff

    Time frame: Day 0

    Transdiaphragmatic pressure measurement during a sniff test

  10. Crying transdiaphragmatic pressure

    Time frame: Day 0

    Transdiaphragmatic pressure measurement during crying in young children

  11. Gastric pressure during cough

    Time frame: Day 0

    Gastric pressure measurement during a maximal cough maneuver

  12. Twitch transdiaphragmatic pressure

    Time frame: Day 0

    Transdiaphragmatic pressure measurement during cervical magnetic stimulation

  13. Inspiratory muscles tension-time index

    Time frame: Day 0

    Measurement of the tension-time index of the inspiratory muscles

  14. Diaphragmatic tension-time index

    Time frame: Day 0

    Measurement of the tension-time index of the diaphragm

  15. Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with the disease severity

    Time frame: Day 0

    The pressure-time product of the respiratory muscles, the work of breathing and the respiratory muscle strength will be correlated with disease severity

  16. Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with polysomnography and gas exchange results

    Time frame: Day 0

    The pressure-time product of the respiratory muscles, the work of breathing and the respiratory muscle strength will be correlated with the polysomnography and gas exchange results

  17. Esophageal pressure-time products in patients with any treatment and in patients with no treatment

    Time frame: Day 0

    The esophageal pressure-time product will be compared between patients with any treatment and patients receiving no treatment

  18. The total work of breathing in patients with any treatment and in patients with no treatment

    Time frame: Day 0

    The total work of breathing (WOBt), which is calculated (in Joules/L) as the area under the pressure-volume curve using the Campbell diagram, be compared between patients with any treatment and patients receiving no traeatment, using the Student t test

  19. Measurement of esophageal pressure during a sniff in patients with any treatment and patients with no treatment

    Time frame: Day 0

    The esophageal pressure during a sniff will be compared between patients with any treatment and patients receiving no treatment

  20. Measurement of the esophageal pressure-time product before and after pharmacological treatment

    Time frame: 6 months and 1 year after treatment initiation

    The esophageal pressure-time product will be compared before treatment, and 6 months and 1 year after pharmacological treatment initiation

  21. The total work of breathing before and after pharmacological treatment

    Time frame: 6 months and 1 year after treatment initiation

    The total work of breathing (WOBt), which is calculated (in Joules/L) as the area under the pressure-volume curve using the Campbell diagram, will be compared before treatment, and 6 months and 1 year after pharmacological treatment initiation, using the ANOVA on repeated measures

  22. Measurement of the esophageal pressure during a sniff before and after pharmacological treatment

    Time frame: 6 months and 1 year after treatment initiation

    The esophageal pressure during a sniff will be compared before treatment, and 6 months and 1 year after pharmacological treatment initiation

  23. Measurement of transdiaphragmatic pressure during a sniff before and after pharmacological treatment

    Time frame: 6 months and 1 year after treatment initiation

    The transdiaphragmatic pressure measurement during a sniff will be compared before treatment, and 6 months and 1 year after pharmacological treatment initiation

  24. Adaptation of the respiratory support according to the esophageal pressure-time product values

    Time frame: Day 0

    The esophageal pressure-time product will be measured to guide the respiratory support adaptation

  25. Adaptation of the respiratory support according to the total work of breathing values

    Time frame: Day 0

    The total work of breathing (WOBt), which is calculated (in Joules/L) as the area under the pressure-volume curve using the Campbell diagram, will be measured to guide the respiratory support adaptation

  26. Measurement of the esophageal pressure-time product in patients with weaning success and in patients with weaning failure

    Time frame: Day 0

    The esophageal pressure-time product will be compared between patients with weaning success and weaning failure

  27. Measurement of the total work of breathing in patients with weaning success and in patients with weaning failure

    Time frame: Day 0

    The total work of breathing (WOBt), which is calculated (in Joules/L) as the area under the pressure-volume curve using the Campbell diagram, will be compared between patients with weaning success and weaning failure, using the Student t test

  28. Measurement of the esophageal pressure during a sniff in patients with weaning success and in patients with weaning failure

    Time frame: Day 0

    The esophageal pressure during a sniff will be compared between patients with weaning success and weaning failure

  29. Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with the gas exchange during weaning trial

    Time frame: Day 0

    The pressure-time product, the work of breathing and the respiratory muscle strength will be correlated with the gas exchange during a weaning trial

Study contacts

Contact information is provided by the study sponsor or research team.

Brigitte FAUROUX, MD, PhD

CONTACT

[email protected]

1 71 19 60 92 ext. +33

Hélène MOREL

CONTACT

[email protected]

1 71 19 63 46 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: WOB&MR_Ped

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Sep 21, 2021
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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