Respiratory Muscles and Work of Breathing in Children

NCT05051254 | Recruiting

• 2 other identifiers: APHP210261ID-RCB 2020-A03393-36
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Esophageal pressure-time product (PTPoes)

  The integral of the esophageal pressure signal over inspiratory time

  Day 0

• Diaphragmatic pressure-time product (PTPdi)

  The integral of the transdiaphragmatic pressure signal over inspiratory time

  Day 0

• 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.

  Day 0

Secondary Outcomes (29)

• Vital capacity

  Day 0

• Maximal respiratory static pressures

  Day 0

• Maximal sniff pressure

  Day 0

• Maximal whistle pressure

  Day 0

• Peak expiratory flow

  Day 0

Study Arms (1)

Respiratory muscle impairment

EXPERIMENTAL

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

Other: Esogastric pressure measurement

Interventions

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.

Respiratory muscle impairment

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases; Hernias, Diaphragmatic, Congenital; Lung Diseases; Heart Diseases; Scoliosis; Respiratory Paralysis

Condition Hierarchy (Ancestors)

Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases; Cardiovascular Diseases; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Respiratory Insufficiency; Respiration Disorders; Paralysis; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Brigitte FAUROUX, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Sonia KHIRANI, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Brigitte FAUROUX, MD, PhD

CONTACT

1 71 19 60 92; brigitte.fauroux@aphp.fr

Hélène MOREL

CONTACT

1 71 19 63 46; helene.morel@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: September 21, 2021
• Study Start: January 19, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)