Respiratory Muscles and Work of Breathing in Children
- Conditions
- Neuromuscular DiseasesCongenital Diaphragmatic HerniaLung DiseasesCardiac DiseasesScoliosisDiaphragmatic ImpairmentRespiratory Muscle Impairment
- Interventions
- Other: Esogastric pressure measurement
- Registration Number
- NCT05051254
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 550
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Respiratory muscle impairment Esogastric pressure measurement Minor patients with primary or secondary impairment of respiratory muscles and followed at Necker Hospital
- Primary Outcome Measures
Name Time Method Esophageal pressure-time product (PTPoes) Day 0 The integral of the esophageal pressure signal over inspiratory time
Diaphragmatic pressure-time product (PTPdi) Day 0 The integral of the transdiaphragmatic pressure signal over inspiratory time
Work of breathing (WOB) 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 Outcome Measures
Name Time Method Esophageal pressure during sniff Day 0 Esophageal pressure measurement during a sniff test
Transdiaphragmatic pressure during sniff Day 0 Transdiaphragmatic pressure measurement during a sniff test
Diaphragmatic tension-time index Day 0 Measurement of the tension-time index of the diaphragm
Vital capacity Day 0 Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation, using spirometry
Maximal respiratory static pressures Day 0 Maximal static inspiratory and expiratory airway pressures
Maximal whistle pressure Day 0 Airway pressure during a whistle test
Peak expiratory flow Day 0 Maximal flow during expiratory maneuver
Twitch transdiaphragmatic pressure Day 0 Transdiaphragmatic pressure measurement during cervical magnetic stimulation
Measurement of the esophageal pressure during a sniff before and after pharmacological treatment 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
Adaptation of the respiratory support according to the esophageal pressure-time product values Day 0 The esophageal pressure-time product will be measured to guide the respiratory support adaptation
Measurement of the esophageal pressure-time product in patients with weaning success and in patients with weaning failure Day 0 The esophageal pressure-time product will be compared between patients with weaning success and weaning failure
Gastric pressure during sniff Day 0 Gastric pressure measurement during a sniff test
Gastric pressure during cough Day 0 Gastric pressure measurement during a maximal cough maneuver
Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with the disease severity 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
Measurement of esophageal pressure during a sniff in patients with any treatment and patients with no treatment Day 0 The esophageal pressure during a sniff will be compared between patients with any treatment and patients receiving no treatment
Measurement of the esophageal pressure-time product before and after pharmacological treatment 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
Adaptation of the respiratory support according to the total work of breathing values 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
Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with the gas exchange during weaning trial 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
Peak cough flow Day 0 Maximal flow during cough
Crying transdiaphragmatic pressure Day 0 Transdiaphragmatic pressure measurement during crying in young children
The total work of breathing before and after pharmacological treatment 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
Measurement of the total work of breathing in patients with weaning success and in patients with weaning failure 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
Inspiratory muscles tension-time index Day 0 Measurement of the tension-time index of the inspiratory muscles
Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with polysomnography and gas exchange results 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
Esophageal pressure-time products in patients with any treatment and in patients with no treatment Day 0 The esophageal pressure-time product will be compared between patients with any treatment and patients receiving no treatment
The total work of breathing in patients with any treatment and in patients with no treatment 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
Measurement of the esophageal pressure during a sniff in patients with weaning success and in patients with weaning failure Day 0 The esophageal pressure during a sniff will be compared between patients with weaning success and weaning failure
Measurement of transdiaphragmatic pressure during a sniff before and after pharmacological treatment 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
Maximal sniff pressure Day 0 Airway pressure during a sniff test
Trial Locations
- Locations (1)
Hôpital Necker-Enfants Malades
🇫🇷Paris, France