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Clinical Trials/NCT05051254
NCT05051254
Recruiting
Not Applicable

Respiratory Muscles and Work of Breathing in Children

Assistance Publique - Hôpitaux de Paris2 sites in 1 country550 target enrollmentJanuary 19, 2022

Overview

Phase
Not Applicable
Intervention
Esogastric pressure measurement
Conditions
Neuromuscular Diseases
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
550
Locations
2
Primary Endpoint
Esophageal pressure-time product (PTPoes)
Status
Recruiting
Last Updated
29 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 19, 2022
End Date
January 1, 2028
Last Updated
29 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Respiratory muscle impairment

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

Intervention: Esogastric pressure measurement

Outcomes

Primary Outcomes

Esophageal pressure-time product (PTPoes)

Time Frame: Day 0

The integral of the esophageal pressure signal over inspiratory time

Diaphragmatic pressure-time product (PTPdi)

Time Frame: Day 0

The integral of the transdiaphragmatic pressure signal over inspiratory time

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

  • Maximal sniff pressure(Day 0)
  • Esophageal pressure during sniff(Day 0)
  • Transdiaphragmatic pressure during sniff(Day 0)
  • Diaphragmatic tension-time index(Day 0)
  • Vital capacity(Day 0)
  • Maximal respiratory static pressures(Day 0)
  • Maximal whistle pressure(Day 0)
  • Peak expiratory flow(Day 0)
  • Twitch transdiaphragmatic pressure(Day 0)
  • Measurement of the esophageal pressure during a sniff before and after pharmacological treatment(6 months and 1 year after treatment initiation)
  • Adaptation of the respiratory support according to the esophageal pressure-time product values(Day 0)
  • Measurement of the esophageal pressure-time product in patients with weaning success and in patients with weaning failure(Day 0)
  • Gastric pressure during sniff(Day 0)
  • Gastric pressure during cough(Day 0)
  • Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with the disease severity(Day 0)
  • Measurement of esophageal pressure during a sniff in patients with any treatment and patients with no treatment(Day 0)
  • Measurement of the esophageal pressure-time product before and after pharmacological treatment(6 months and 1 year after treatment initiation)
  • Adaptation of the respiratory support according to the total work of breathing values(Day 0)
  • Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with the gas exchange during weaning trial(Day 0)
  • Peak cough flow(Day 0)
  • Crying transdiaphragmatic pressure(Day 0)
  • The total work of breathing before and after pharmacological treatment(6 months and 1 year after treatment initiation)
  • Measurement of the total work of breathing in patients with weaning success and in patients with weaning failure(Day 0)
  • Inspiratory muscles tension-time index(Day 0)
  • Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with polysomnography and gas exchange results(Day 0)
  • Esophageal pressure-time products in patients with any treatment and in patients with no treatment(Day 0)
  • The total work of breathing in patients with any treatment and in patients with no treatment(Day 0)
  • Measurement of the esophageal pressure during a sniff in patients with weaning success and in patients with weaning failure(Day 0)
  • Measurement of transdiaphragmatic pressure during a sniff before and after pharmacological treatment(6 months and 1 year after treatment initiation)

Study Sites (2)

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