Respiratory Muscles and Work of Breathing in Children

Lung Diseases Clinical Trial

— WOB&MR_Ped  

Official title:

Respiratory Muscles and Work of Breathing in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05051254
• Other study ID #: APHP210261
• Secondary ID: ID-RCB 2020-A033
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2022
• Est. completion date: January 2028

Study information

• Verified date: February 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Brigitte FAUROUX, MD, PhD
• Phone: 1 71 19 60 92
• Email: brigitte.fauroux[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Diseases
• Congenital Diaphragmatic Hernia
• Heart Diseases
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital
• Lung Diseases
• Neuromuscular Diseases
• Respiratory Aspiration
• Scoliosis

Intervention

Other:
• Esogastric pressure measurement
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.

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophageal pressure-time product (PTPoes)	The integral of the esophageal pressure signal over inspiratory time	Day 0
Primary	Diaphragmatic pressure-time product (PTPdi)	The integral of the transdiaphragmatic pressure signal over inspiratory time	Day 0
Primary	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	Vital capacity	Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation, using spirometry	Day 0
Secondary	Maximal respiratory static pressures	Maximal static inspiratory and expiratory airway pressures	Day 0
Secondary	Maximal sniff pressure	Airway pressure during a sniff test	Day 0
Secondary	Maximal whistle pressure	Airway pressure during a whistle test	Day 0
Secondary	Peak expiratory flow	Maximal flow during expiratory maneuver	Day 0
Secondary	Peak cough flow	Maximal flow during cough	Day 0
Secondary	Esophageal pressure during sniff	Esophageal pressure measurement during a sniff test	Day 0
Secondary	Gastric pressure during sniff	Gastric pressure measurement during a sniff test	Day 0
Secondary	Transdiaphragmatic pressure during sniff	Transdiaphragmatic pressure measurement during a sniff test	Day 0
Secondary	Crying transdiaphragmatic pressure	Transdiaphragmatic pressure measurement during crying in young children	Day 0
Secondary	Gastric pressure during cough	Gastric pressure measurement during a maximal cough maneuver	Day 0
Secondary	Twitch transdiaphragmatic pressure	Transdiaphragmatic pressure measurement during cervical magnetic stimulation	Day 0
Secondary	Inspiratory muscles tension-time index	Measurement of the tension-time index of the inspiratory muscles	Day 0
Secondary	Diaphragmatic tension-time index	Measurement of the tension-time index of the diaphragm	Day 0
Secondary	Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with the disease severity	The pressure-time product of the respiratory muscles, the work of breathing and the respiratory muscle strength will be correlated with disease severity	Day 0
Secondary	Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with polysomnography and gas exchange results	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	Day 0
Secondary	Esophageal pressure-time products in patients with any treatment and in patients with no treatment	The esophageal pressure-time product will be compared between patients with any treatment and patients receiving no treatment	Day 0
Secondary	The total work of breathing in patients with any treatment and in patients with no treatment	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	Day 0
Secondary	Measurement of esophageal pressure during a sniff in patients with any treatment and patients with no treatment	The esophageal pressure during a sniff will be compared between patients with any treatment and patients receiving no treatment	Day 0
Secondary	Measurement of the esophageal pressure-time product before and after pharmacological treatment	The esophageal pressure-time product will be compared before treatment, and 6 months and 1 year after pharmacological treatment initiation	6 months and 1 year after treatment initiation
Secondary	The total work of breathing before and after pharmacological treatment	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	6 months and 1 year after treatment initiation
Secondary	Measurement of the esophageal pressure during a sniff before and after pharmacological treatment	The esophageal pressure during a sniff will be compared before treatment, and 6 months and 1 year after pharmacological treatment initiation	6 months and 1 year after treatment initiation
Secondary	Measurement of transdiaphragmatic pressure during a sniff before and after pharmacological treatment	The transdiaphragmatic pressure measurement during a sniff will be compared before treatment, and 6 months and 1 year after pharmacological treatment initiation	6 months and 1 year after treatment initiation
Secondary	Adaptation of the respiratory support according to the esophageal pressure-time product values	The esophageal pressure-time product will be measured to guide the respiratory support adaptation	Day 0
Secondary	Adaptation of the respiratory support according to the total work of breathing values	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	Day 0
Secondary	Measurement of the esophageal pressure-time product in patients with weaning success and in patients with weaning failure	The esophageal pressure-time product will be compared between patients with weaning success and weaning failure	Day 0
Secondary	Measurement of the total work of breathing in patients with weaning success and in patients with weaning failure	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	Day 0
Secondary	Measurement of the esophageal pressure during a sniff in patients with weaning success and in patients with weaning failure	The esophageal pressure during a sniff will be compared between patients with weaning success and weaning failure	Day 0
Secondary	Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with the gas exchange during weaning trial	The pressure-time product, the work of breathing and the respiratory muscle strength will be correlated with the gas exchange during a weaning trial	Day 0