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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02466-43 | Other Identifier | ID-RCB |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium chloride (NaCl) | Experimental | The first 12 patients will be included in this group, with at least 6 patients weighing less than 20 kg. After a breath hold, a saline solution (NaCl 5% at 0.3 mL/kg; maximum 10 mL) will be injected over a few seconds with EIT acquisition. After 4 to 6 hours, a second acquisition will be performed using the same volume and concentration if the signal is correct. If the signal is insufficient, the injected volume will be increased to 0.5 mL/kg in children weighing less than 20 kg, and the saline concentration will be increased to 7.5% in children weighing more than 20 kg. |
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| Sodium bicarbonate | Experimental | The last 8 patients will be included in this group, with at least 4 patients weighing less than 20 kg. After a breath hold, a saline bicarbonate solution (4.2%, 0.5 mL/kg; maximum 10 mL) will be injected over a few seconds with EIT acquisition. After 4 to 6 hours, a second acquisition will be performed using the same volume and concentration (no volume or concentration adjustment will be made in this group). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate | Other | 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 impedance signal variation induced by the saline solution injection is at least equivalent to the amplitude variation observed during ventilation with a tidal volume of 8 mL/kg. 2 measurements at 4 to 6-hours intervals with volume or concentration adjustment after the first injection if needed in the group 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with pulmonary perfusion acquisition consider as valid | Data acquisition will be considered valid if the impedance signal variation induced by the saline solution injection is at least equivalent to the amplitude variation observed during ventilation with a tidal volume of 8 mL/kg. | Hour 0 ; Between Hour 4 and Hour 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients requiring an increase in volume and/or concentration of saline solution | Increase in the volume and/or concentration of the saline solution due to insufficient signal detection during the first injection (Group 1). | Between Hour 4 and Hour 6 |
| Proportion of respiratory acquisition failures explained by breathing movements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florent BAUDIN, Pr | Contact | 04 72 12 97 05 | florent.baudin@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florent BAUDIN | Recruiting | Bron | France | 69500 | France |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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Model Description
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Data acquisition failure related to variations in the airway pressure waveform recorded by the software. |
| Hour 0 ; Between Hour 4 and Hour 6 |
| Distribution of pulmonary perfusion | Description of the distribution of regional pulmonary perfusion in children, expressed as percentages across predefined regions of interest (right versus left and anterior versus posterior). | Hour 0 ; Between Hour 4 and Hour 6 |
| Natremia variation after injection | Serum sodium concentration (mmol/L) measured before and after injection, with calculation of absolute (mmol/L) and relative (%) changes. | Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7 |
| Natremia variation at day one | Serum sodium concentration (mmol/L) measured at baseline and on day 1, with calculation of absolute (mmol/L) and relative (%) changes from baseline. | Hour 0 ; Hour 24 |
| Heart rate variation | Heart rate (beats/min) measured before and after saline solution injection, with calculation of absolute (beats/min) and relative (%) changes | Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7 |
| Blood pressure variation | Systolic, diastolic, and mean arterial blood pressure measured before and after saline solution injection, with calculation of absolute (mmHg) and relative (%) changes. | Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7 |
| Significant hemodynamic events | Any change in heart rate or systolic blood pressure > 15% from baseline | Through study completion, an average of 24 hours |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |