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Recruiting NCT07532811

Evaluation of Perfusion and Ventilation Distribution in Children: a Pilot Study.

No phase Interventional Acute Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate.
Who it may be relevant to
Registry conditions: Acute Respiratory Failure. Basic parameters: up to 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Feasibility Study of the Evaluation of Perfusion and Ventilation Distribution in Children : a Pilot Study

Overview

Electrical impedance tomography (EIT) is a recent monitoring technique that provides information on regional ventilation distribution. Following the injection of a hypertonic saline bolus, EIT can also assess regional pulmonary perfusion distribution, allowing evaluation of the ventilation/perfusion (V/Q) ratio. In adults, protocols for assessing perfusion distribution require the injection of 10 mL of a 7.5% or 10% NaCl solution or sodium bicarbonate over a few seconds. Studies have reported good hemodynamic tolerance, adequate image quality, and no significant changes in serum sodium levels. However, this volume and sodium load are not appropriate for small children. To date, no pediatric protocol exists for assessing pulmonary perfusion distribution and the ventilation/perfusion ratio using EIT. It is therefore proposed to conduct a pilot study to evaluate the feasibility of assessing pulmonary perfusion by EIT using a weight-adjusted bolus of hypertonic saline (NaCl or sodium bicarbonate).

Interventions

  • Other Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate
    All patients will undergo EIT monitoring (Enlight 2100, Timpel, Brazil) using a belt adjusted to the thoracic circumference. Ventilation distribution will be assessed with a tidal volume of 8 mL/kg. Following a breath hold, a saline solution (sodium chloride or sodium bicarbonate) will be injected over a few seconds. Perfusion distribution, as well as impedance signal variation, will be recorded using dedicated software (Timpel, Brazil). Data acquisition will be considered valid if the impedan

Primary outcome measures

  • Proportion of patients with pulmonary perfusion acquisition consider as valid [Time frame: Hour 0 ; Between Hour 4 and Hour 6]
Secondary outcome measures (8)
  • Proportion of patients requiring an increase in volume and/or concentration of saline solution [Time frame: Between Hour 4 and Hour 6]
  • Proportion of respiratory acquisition failures explained by breathing movements [Time frame: Hour 0 ; Between Hour 4 and Hour 6]
  • Distribution of pulmonary perfusion [Time frame: Hour 0 ; Between Hour 4 and Hour 6]
  • Natremia variation after injection [Time frame: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7]
  • Natremia variation at day one [Time frame: Hour 0 ; Hour 24]
  • Heart rate variation [Time frame: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7]
  • Blood pressure variation [Time frame: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7]
  • Significant hemodynamic events [Time frame: Through study completion, an average of 24 hours]

Eligibility criteria

Inclusion criteria

  • patients < 12 years hospitalized in pediatric intensive care
  • intubated, under conventional invasive mechanical ventilation and sedated
  • between 3 and 40 kg
  • with central venous access in the superior vena cava
  • consent signed by parents or legal guardians

Exclusion criteria

  • Patients with significant leaks > 20% around the endotracheal tube
  • Patients receiving spontaneous ventilation (inspiratory support, NIV, etc.)
  • Natremia > 150 mmol/L at inclusion
  • Hyperchloremia ≥ 115 mmol/L and/or hypokaliema ≤ 3 mmol/L
  • Patients with intracranial hypertension
  • Patients with active bleeding or persistent hemodynamic instability despite amines
  • Patients with heart failure, uncorrected cyanotic heart disease, or a history of cardiac arrhythmia
  • Patients with contraindications to the use of the electrical impedance pulmonary tomography belt (skin lesions, burns, or recent thoracic surgery)
  • Conditions in which EIT data acquisition will be disrupted (chest dressings, pneumothorax, ECMO)
  • Patients with severe hypoxemia defined as FiO2 > 90% to maintain SpO2 > 88%
  • Individuals not affiliated with a social security system or beneficiaries of a similar system

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Florent BAUDIN — Bron

Identifiers

NCT: NCT07532811 · 69HCL25_0492 · 2025-A02466-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗