An interventional study of Thoracic electric impedance tomography to assed regional ventilation and Positive end-expiratory pressure (PEEP) trial titration in Pediatric Acute Respiratory Failure, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Supportive care
Mechanical ventilation can lead to pulmonary, diaphragmatic, and hemodynamic complications due to an increase in global and regional transpulmonary pressure. Optimizing protective mechanical ventilation by using low tidal volumes and positive end-expiratory pressure (PEEP), or by positioning the patient in prone position, is recommended to limit these effects.
Prone positioning during mechanical ventilation results in: i) a decrease in airway resistance; ii) a decrease in thoracic compliance, which leads to a redistribution of ventilation-perfusion ratios and, consequently, more homogeneous ventilation. In adults with acute respiratory distress syndrome, prone position reduces mortality and the duration of ventilation. The physiological benefits of prone position, along with its ease of implementation in children, make its use common in pediatrics. However, the clinical benefit of this practice in children has never been demonstrated. The effect of prone position is, hard to predict and varies from one patient to another. The heterogeneity of children in terms of age and respiratory mechanics highlights the importance of individualizing mechanical ventilation in this population, in order to identify which children might benefit from this practice.
Thoracic electrical impedance tomography (EIT) is the only technique that allows for real-time, noninvasive, and radiation-free assessment of pulmonary ventilation distribution at the patient's bedside. In children, it can be easily performed without any additional risk. In this population, a few studies have described the heterogeneity of lung volumes induced by recruitment maneuvers or different ventilation settings using thoracic electrical impedance.
The impact of the response to prone positioning on the improvement of global and regional respiratory mechanics has not yet been evaluated.
This study is a comparative cohort study (with each subject serving as their own control) conducted in the pediatric intensive care unit at Necker-Enfants Malades Hospital in Paris, France.
Mechanical ventilation can lead to pulmonary, diaphragmatic, and hemodynamic complications due to an increase in global and regional transpulmonary pressure. Optimizing protective mechanical ventilation by using low tidal volumes and positive end-expiratory pressure (PEEP), or by positioning the patient in prone position, is recommended to limit these effects.
Prone positioning during mechanical ventilation results in: i) a decrease in airway resistance; ii) a decrease in thoracic compliance, which leads to a redistribution of ventilation-perfusion ratios and, consequently, more homogeneous ventilation. In adults with acute respiratory distress syndrome, prone position reduces mortality and the duration of ventilation. The physiological benefits of prone position, along with its ease of implementation in children, make its use common in pediatrics. However, the clinical benefit of this practice in children has never been demonstrated. The effect of prone position is, hard to predict and varies from one patient to another. The heterogeneity of children in terms of age and respiratory mechanics highlights the importance of individualizing mechanical ventilation in this population, in order to identify which children might benefit from this practice.
Thoracic electrical impedance tomography (EIT) is the only technique that allows for real-time, noninvasive, and radiation-free assessment of pulmonary ventilation distribution at the patient's bedside. In children, it can be easily performed without any additional risk. In this population, a few studies have described the heterogeneity of lung volumes induced by recruitment maneuvers or different ventilation settings using thoracic electrical impedance.
Patients will be enrolled in pediatric intensive care units. There are no pediatric guidelines regarding age-specific ventilator settings for ventilated children. As part of this study, each patient will therefore be evaluated as their own control before and after being placed in the prone position.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Minors aged 0 to 18 years admitted to the pediatric intensive care unit at Necker-Enfants Malades Hospital and receiving controlled invasive mechanical ventilation (no spontaneous breathing) for an expected duration of at least 16 hours, with an indication for an initial prone positioning session (regardless of the indication, left to the clinician's discretion in the absence of specific recommendations for children).
Device: Thoracic electric impedance tomography to assed regional ventilation · Other: Positive end-expiratory pressure (PEEP) trial titration · Other: Collection of clinical Data
The system provides real-time visualization of tidal impedance changes (ΔZ), end-expiratory lung impedance (EELI), regional ventilation delay (RVD), the percentage of overdistension, and the percentage of lung collapse within the different lung regions analyzed. EIT images will be divided into several symmetrical, non-overlapping regions of interest (ROIs) according to a ventral-to-dorsal horizontal gradient. The EIT analysis software (Pulmovista, Dräger) will be connected to the ventilator to acquire tidal volume (Vt) and airway pressure measurements, including end-inspiratory plateau pressure (Pplat) and positive end-expiratory pressure (PEEP), allowing calculation of regional lung compliance (Creg=(Pplat-PEEP)/ΔZ). At each study time point, physiological data will be continuously recorded for 20 minutes. Offline analyses will be performed using the final 5 minutes of each recording with the manufacturer's dedicated software (P500, Dräger).
positive end-expiratory pressure trial titration will be performed at H1 and H16 of prone position, using an incremental followed by a decremental adjustment of the PEEP level: for newborns (\<1 month), adjustments will be made in 1 cmH₂O increments, ranging from 4 to 12 cmH₂O. For children older than one month, adjustments will be made in 2-cmH₂O increments, ranging from 4 to 18 cmH₂O. At each step, 10 ventilatory cycles per PEEP level will be recorded, with a maximum procedure duration of 5 minutes (assuming an average respiratory rate of 40/min for newborns and a maximum of 20/min for older children). At the end of the procedure, the usual ventilatory settings will be resumed.
Collection of clinical data during ICU stayand 28 days after the patient's participation in the study, derived from the patient's medical record.
Change in regional lung ventilation distribution
Change in regional lung ventilation distribution assessed by thoracic electrical impedance tomography (EIT) (ΔZ) expressed as the percentage change in ΔZ relative to the reference condition (supine position).
Time frame: Before and after 1 hour, 6 hours and 16 hours of prone position
Optimal positive end-expiratory pressure trial level
Optimal positive end-expiratory pressure trial level.
Time frame: Before and after 1 hour and 16 hours of prone position
Respiratory System Compliance
Respiratory system compliance (Crs) computed as (Pplat-PEEP)/Vt.
Time frame: Before and after 1 hour, 6 hours and 16 hours of prone position
Oxygen Saturation Index (OSI)
Computed as OSI = (PmxFiO2x100)/SpO2, where Pm is the mean pressure of the respiratory system (collected on the ventilator), FiO2 is the inspired fraction of oxygen, SpO2 is the pulsed oxygen saturation. Patients will be considered as prone position responders if their OSI increases of more than 10% after prone position.
Time frame: After 1 hour and after 16 hours of prone position
Number of days without ventilation
Data collected from the patient's medical record.
Time frame: 28 days after the first prone positioning
Death at 28 days
Data collected from the patient's medical record.
Time frame: 28 days after the first prone positioning
Change in Regional Compliance
Change in Regional Compliance assessed by EIT (ΔCreg), expressed as the percentage change in ΔCreg relative to the reference condition (supine position).
Time frame: Before and after 1 hour, 6 hours and 16 hours of prone positioning
Change in End-Expiratory Lung Impedance
Change in End-Expiratory Lung Impedance assessed by EIT (ΔEELI), expressed in arbitrary units (AU), relative to the reference condition (supine position).
Time frame: Before and after 1 hour, 6 hours and 16 hours of prone positioning
Change in the proportion of tidal ventilation distributed to the dorsal lung regions
Change in the proportion of tidal ventilation distributed to the dorsal lung regions, calculated as ΔZdorsal/ΔZtotal × 100, relative to the reference condition (supine position).
Time frame: Before and after 1 hour, 6 hours and 16 hours of prone positioning
Change in the Center of Ventilation
Change in the Center of Ventilation (CoV) assessed by EIT. A CoV of 0.5 indicates a centrally distributed ventilation pattern, whereas values below or above 0.5 indicate predominantly ventral or dorsal ventilation, respectively.
Time frame: Before and after 1 hour, 6 hours and 16 hours of prone positioning
Change in the Global Inhomogeneity
Change in the Global Inhomogeneity (GI) index assessed by EIT. Lower values indicate a more homogeneous distribution of ventilation, whereas higher values reflect greater ventilation inhomogeneity.
Time frame: Before and after 1 hour, 6 hours and 16 hours of prone positioning
Change in the percentage of lung regions exhibiting Regional Ventilation Delay
Change in the percentage of lung regions exhibiting Regional Ventilation Delay (RVD), assessed by EIT.
Time frame: Before and after 1 hour, 6 hours and 16 hours of prone positioning
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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