Regional Lung Ventilation During Prone Position in in Intubated Children
NCT07921745, Not applicable, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Regional Lung Ventilation During Prone Position in in Intubated Children | ClinicalTrials.gov |
| NCT number | NCT07921745 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris | ClinicalTrials.gov |
| Conditions | Pediatric Acute Respiratory Failure | ClinicalTrials.gov |
| Interventions | Thoracic electric impedance tomography to assed regional ventilation, Positive end-expiratory pressure (PEEP) trial titration, Collection of clinical Data | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in regional lung ventilation distribution | 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). | ClinicalTrials.gov |
| Secondary | Optimal positive end-expiratory pressure trial level | Before and after 1 hour and 16 hours of prone position | Optimal positive end-expiratory pressure trial level. | ClinicalTrials.gov |
| Secondary | Respiratory System Compliance | Before and after 1 hour, 6 hours and 16 hours of prone position | Respiratory system compliance (Crs) computed as (Pplat-PEEP)/Vt. | ClinicalTrials.gov |
| Secondary | Oxygen Saturation Index (OSI) | After 1 hour and after 16 hours of prone position | 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. | ClinicalTrials.gov |
| Secondary | Number of days without ventilation | 28 days after the first prone positioning | Data collected from the patient's medical record. | ClinicalTrials.gov |
| Secondary | Death at 28 days | 28 days after the first prone positioning | Data collected from the patient's medical record. | ClinicalTrials.gov |
| Secondary | Change in Regional Compliance | Before and after 1 hour, 6 hours and 16 hours of prone positioning | Change in Regional Compliance assessed by EIT (ΔCreg), expressed as the percentage change in ΔCreg relative to the reference condition (supine position). | ClinicalTrials.gov |
| Secondary | Change in End-Expiratory Lung Impedance | Before and after 1 hour, 6 hours and 16 hours of prone positioning | Change in End-Expiratory Lung Impedance assessed by EIT (ΔEELI), expressed in arbitrary units (AU), relative to the reference condition (supine position). | ClinicalTrials.gov |
| Secondary | Change in the proportion of tidal ventilation distributed to the dorsal lung regions | 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, calculated as ΔZdorsal/ΔZtotal × 100, relative to the reference condition (supine position). | ClinicalTrials.gov |
| Secondary | Change in the Center of Ventilation | Before and after 1 hour, 6 hours and 16 hours of prone positioning | 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. | ClinicalTrials.gov |
| Secondary | Change in the Global Inhomogeneity | Before and after 1 hour, 6 hours and 16 hours of prone positioning | 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. | ClinicalTrials.gov |
| Secondary | Change in the percentage of lung regions exhibiting Regional Ventilation Delay | Before and after 1 hour, 6 hours and 16 hours of prone positioning | Change in the percentage of lung regions exhibiting Regional Ventilation Delay (RVD), assessed by EIT. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 10
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)