Pediatric Acute Respiratory FailureChildProne-EITNCT07921745
Regional Lung Ventilation During Prone Position in in Intubated Children
A study testing Thoracic electric impedance tomography to assed regional ventilation, Positive end-expiratory pressure (PEEP) trial titration and Collection of clinical Data in people with Pediatric Acute Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Acute Respiratory Failure
- What is being tested?
- Thoracic electric impedance tomography to assed regional ventilation, Positive end-expiratory pressure (PEEP) trial titration and Collection of clinical Data
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 0 to 18 years
- on controlled invasive mechanical ventilation (no spontaneous breathing) for an expected duration of at least 16 hours
- for whom an initial prone positioning session is indicated (regardless of the indication; left to the clinician's discretion)
- notification of legal guardians and written consent from legal guardians
Who cannot join
- Corrected gestational age ≤ 37 weeks
- Contraindication or impracticality of Thoracic electrical impedance tomography : presence of a pacemaker or a bandages covering chest wall, significant skin lesions
- Pneumothorax or pneumomediastinum
- Significant hemodynamic instability (rapid increase in vasoactive or inotropic agents to maintain adequate peripheral circulation and blood pressure), refractory hypoxemia, or moribund patient
- Child on unconventional mode of invasive ventilation (high-frequency oscillatory ventilation) or noninvasive ventilatory support
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Necker-Enfants Malades, AP-HP
Paris, 75015
Meryl Vedrenne-Cloquet, MD, 0033134292369, meryl.vedrenne@aphp.fr
Charlotte Collignon, MD
About this study
Official title: Effects of Prone Positioning on Regional Lung Ventilation Assessed by Electroimpedance Tomography (EIT) in Intubated Children
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Pediatric Acute Respiratory Failure
- Being tested
- Thoracic electric impedance tomography to assed regional ventilation, Positive end-expiratory pressure (PEEP) trial titration, Collection of clinical Data
- Keywords
- Invasively Ventilated Children, Regional Lung Ventilation, Prone position, Thoracic electrical impedance tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic electric impedance tomography to assed regional ventilationDevice
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 (PEEP) trial titrationOther
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 DataOther
Collection of clinical data during ICU stayand 28 days after the patient's participation in the study, derived from the patient's medical record.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | 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). Receives: Device: Thoracic electric impedance tomography to assed regional ventilation; Other: Positive end-expiratory pressure (PEEP) trial titration; Other: Collection of clinical Data |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before and after 1 hour, 6 hours and 16 hours of prone position
Secondary outcomes (11)
Optimal positive end-expiratory pressure trial level
Optimal positive end-expiratory pressure trial level.
Measured: Before and after 1 hour and 16 hours of prone position
Respiratory System Compliance
Respiratory system compliance (Crs) computed as (Pplat-PEEP)/Vt.
Measured: 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.
Measured: After 1 hour and after 16 hours of prone position
Number of days without ventilation
Data collected from the patient's medical record.
Measured: 28 days after the first prone positioning
Death at 28 days
Data collected from the patient's medical record.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and after 1 hour, 6 hours and 16 hours of prone positioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pediatric Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Meryl Vedrenne-Cloquet, Study director, Assistance Publique - Hôpitaux de Paris, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921745
- Sponsor's protocol ID
- APHP251928
- Other IDs
- 2025-A02496-43
- Acronym
- ChildProne-EIT
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Emeriaud G, Lopez-Fernandez YM, Iyer NP, Bembea MM, Agulnik A, Barbaro RP, Baudin F, Bhalla A, Brunow de Carvalho W, Carroll CL, Cheifetz IM, Chisti MJ, Cruces P, Curley MAQ, Dahmer MK, Dalton HJ, Erickson SJ, Essouri S, Fernandez A, Flori HR, Grunwell JR, Jouvet P, Killien EY, Kneyber MCJ, Kudchadkar SR, Korang SK, Lee JH, Macrae DJ, Maddux A, Modesto I Alapont V, Morrow BM, Nadkarni VM, Napolitano N, Newth CJL, Pons-Odena M, Quasney MW, Rajapreyar P, Rambaud J, Randolph AG, Rimensberger P, Rowan CM, Sanchez-Pinto LN, Sapru A, Sauthier M, Shein SL, Smith LS, Steffen K, Takeuchi M, Thomas NJ, Tse SM, Valentine S, Ward S, Watson RS, Yehya N, Zimmerman JJ, Khemani RG; Second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) Group on behalf of the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Executive Summary of the Second International Guidelines for the Diagnosis and Management of Pediatric Acute Respiratory Distress Syndrome (PALICC-2). Pediatr Crit Care Med. 2023 Feb 1;24(2):143-168. doi: 10.1097/PCC.0000000000003147. Epub 2023 Jan 20.
PubMed 36661420Lupton-Smith A, Argent A, Rimensberger P, Frerichs I, Morrow B. Prone Positioning Improves Ventilation Homogeneity in Children With Acute Respiratory Distress Syndrome. Pediatr Crit Care Med. 2017 May;18(5):e229-e234. doi: 10.1097/PCC.0000000000001145.
PubMed 28328787Inany HS, Rettig JS, Smallwood CD, Arnold JH, Walsh BK. Distribution of Ventilation Measured by Electrical Impedance Tomography in Critically Ill Children. Respir Care. 2020 May;65(5):590-595. doi: 10.4187/respcare.07076. Epub 2020 Jan 28.
PubMed 31992677Becher TH, Miedema M, Kallio M, Papadouri T, Karaoli C, Sophocleous L, Rahtu M, van Leuteren RW, Waldmann AD, Strodthoff C, Yerworth R, Dupre A, Benissa MR, Nordebo S, Khodadad D, Bayford R, Vliegenthart R, Rimensberger PC, van Kaam AH, Frerichs I. Prolonged Continuous Monitoring of Regional Lung Function in Infants with Respiratory Failure. Ann Am Thorac Soc. 2022 Jun;19(6):991-999. doi: 10.1513/AnnalsATS.202005-562OC.
PubMed 34898392Songsangvorn N, Xu Y, Lu C, Rotstein O, Brochard L, Slutsky AS, Burns KEA, Zhang H. Electrical impedance tomography-guided positive end-expiratory pressure titration in ARDS: a systematic review and meta-analysis. Intensive Care Med. 2024 May;50(5):617-631. doi: 10.1007/s00134-024-07362-2. Epub 2024 Mar 21.
PubMed 38512400Franchineau G, Brechot N, Hekimian G, Lebreton G, Bourcier S, Demondion P, Le Guennec L, Nieszkowska A, Luyt CE, Combes A, Schmidt M. Prone positioning monitored by electrical impedance tomography in patients with severe acute respiratory distress syndrome on veno-venous ECMO. Ann Intensive Care. 2020 Feb 3;10(1):12. doi: 10.1186/s13613-020-0633-5.
PubMed 32016593Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
PubMed 27596161Curley MA, Hibberd PL, Fineman LD, Wypij D, Shih MC, Thompson JE, Grant MJ, Barr FE, Cvijanovich NZ, Sorce L, Luckett PM, Matthay MA, Arnold JH. Effect of prone positioning on clinical outcomes in children with acute lung injury: a randomized controlled trial. JAMA. 2005 Jul 13;294(2):229-37. doi: 10.1001/jama.294.2.229.
PubMed 16014597Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
PubMed 23688302Numa AH, Hammer J, Newth CJ. Effect of prone and supine positions on functional residual capacity, oxygenation, and respiratory mechanics in ventilated infants and children. Am J Respir Crit Care Med. 1997 Oct;156(4 Pt 1):1185-9. doi: 10.1164/ajrccm.156.4.9601042.
PubMed 9351620
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prone Positioning on Regional Lung Ventilation Assessed by Electroimpedance Tomography (EIT) in Intubated Children
- ClinicalTrials.gov ID
- NCT07921745
- Acronym / sponsor ID
- ChildProne-EIT / APHP251928
- Conditions
- Pediatric Acute Respiratory Failure
- Keywords
- Invasively Ventilated Children, Regional Lung Ventilation, Prone position, Thoracic electrical impedance tomography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: Thoracic electric impedance tomography to assed regional ventilation, Other: Positive end-expiratory pressure (PEEP) trial titration, Other: Collection of clinical DataMinors 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). |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients aged 0 to 18 years
- on controlled invasive mechanical ventilation (no spontaneous breathing) for an expected duration of at least 16 hours
- for whom an initial prone positioning session is indicated (regardless of the indication; left to the clinician's discretion)
- notification of legal guardians and written consent from legal guardians
Key exclusion criteria (5 listed)
- Corrected gestational age ≤ 37 weeks
- Contraindication or impracticality of Thoracic electrical impedance tomography : presence of a pacemaker or a bandages covering chest wall, significant skin lesions
- Pneumothorax or pneumomediastinum
- Significant hemodynamic instability (rapid increase in vasoactive or inotropic agents to maintain adequate peripheral circulation and blood pressure), refractory hypoxemia, or moribund patient
- Child on unconventional mode of invasive ventilation (high-frequency oscillatory ventilation) or noninvasive ventilatory support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic electric impedance tomography to assed regional ventilationThe 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). | Device | Patients |
| Positive end-expiratory pressure (PEEP) trial titrationpositive 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. | Other | Patients |
| Collection of clinical DataCollection of clinical data during ICU stayand 28 days after the patient's participation in the study, derived from the patient's medical record. | Other | Patients |
Primary outcome
Change in regional lung ventilation distribution
Time frame: Before and after 1 hour, 6 hours and 16 hours of prone position
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).
11 secondary outcomes
Optimal positive end-expiratory pressure trial level
Time frame: Before and after 1 hour and 16 hours of prone position
Respiratory System Compliance
Time frame: Before and after 1 hour, 6 hours and 16 hours of prone position
Oxygen Saturation Index (OSI)
Time frame: After 1 hour and after 16 hours of prone position
Number of days without ventilation
Time frame: 28 days after the first prone positioning
Death at 28 days
Time frame: 28 days after the first prone positioning
Change in Regional Compliance
Time frame: Before and after 1 hour, 6 hours and 16 hours of prone positioning
Change in End-Expiratory Lung Impedance
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
Time frame: Before and after 1 hour, 6 hours and 16 hours of prone positioning
Change in the Center of Ventilation
Time frame: Before and after 1 hour, 6 hours and 16 hours of prone positioning
Change in the Global 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
Time frame: Before and after 1 hour, 6 hours and 16 hours of prone positioning
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 36661420Emeriaud G, Lopez-Fernandez YM, Iyer NP, Bembea MM, Agulnik A, Barbaro RP, Baudin F, Bhalla A, Brunow de Carvalho W, Carroll CL, Cheifetz IM, Chisti MJ, Cruces P, Curley MAQ, Dahmer MK, Dalton HJ, Erickson SJ, Essouri S, Fernandez A, Flori HR, Grunwell JR, Jouvet P, Killien EY, Kneyber MCJ, Kudchadkar SR, Korang SK, Lee JH, Macrae DJ, Maddux A, Modesto I Alapont V, Morrow BM, Nadkarni VM, Napolitano N, Newth CJL, Pons-Odena M, Quasney MW, Rajapreyar P, Rambaud J, Randolph AG, Rimensberger P, Rowan CM, Sanchez-Pinto LN, Sapru A, Sauthier M, Shein SL, Smith LS, Steffen K, Takeuchi M, Thomas NJ, Tse SM, Valentine S, Ward S, Watson RS, Yehya N, Zimmerman JJ, Khemani RG; Second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) Group on behalf of the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Executive Summary of the Second International Guidelines for the Diagnosis and Management of Pediatric Acute Respiratory Distress Syndrome (PALICC-2). Pediatr Crit Care Med. 2023 Feb 1;24(2):143-168. doi: 10.1097/PCC.0000000000003147. Epub 2023 Jan 20.
- Background: PubMed 28328787Lupton-Smith A, Argent A, Rimensberger P, Frerichs I, Morrow B. Prone Positioning Improves Ventilation Homogeneity in Children With Acute Respiratory Distress Syndrome. Pediatr Crit Care Med. 2017 May;18(5):e229-e234. doi: 10.1097/PCC.0000000000001145.
- Background: PubMed 31992677Inany HS, Rettig JS, Smallwood CD, Arnold JH, Walsh BK. Distribution of Ventilation Measured by Electrical Impedance Tomography in Critically Ill Children. Respir Care. 2020 May;65(5):590-595. doi: 10.4187/respcare.07076. Epub 2020 Jan 28.
- Background: PubMed 34898392Becher TH, Miedema M, Kallio M, Papadouri T, Karaoli C, Sophocleous L, Rahtu M, van Leuteren RW, Waldmann AD, Strodthoff C, Yerworth R, Dupre A, Benissa MR, Nordebo S, Khodadad D, Bayford R, Vliegenthart R, Rimensberger PC, van Kaam AH, Frerichs I. Prolonged Continuous Monitoring of Regional Lung Function in Infants with Respiratory Failure. Ann Am Thorac Soc. 2022 Jun;19(6):991-999. doi: 10.1513/AnnalsATS.202005-562OC.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meryl Vedrenne-Cloquet study director
Assistance Publique - Hôpitaux de Paris, AP-HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic electric impedance tomography to assed regional ventilation, Positive end-expiratory pressure (PEEP) trial titration and Collection of clinical Data in people with Pediatric Acute Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meryl Vedrenne-Cloquet, MD (0033134292369, meryl.vedrenne@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in regional lung ventilation distribution (time frame: Before and after 1 hour, 6 hours and 16 hours of prone position). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07921745, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.