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

NCT07532811 | Not Yet Recruiting

• 2 other identifiers: 69HCL25_04922025-A02466-43
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Respiratory Failure

Keywords

Electrical impedance tomography; Pediatric intensive care unit; Perfusion and ventilation distribution

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Proportion of patients requiring an increase in volume and/or concentration of saline solution

  Between Hour 4 and Hour 6

• Proportion of respiratory acquisition failures explained by breathing movements

  Hour 0 ; Between Hour 4 and Hour 6

• Distribution of pulmonary perfusion

  Hour 0 ; Between Hour 4 and Hour 6

• Natremia variation after injection

  Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7

• Natremia variation at day one

  Hour 0 ; Hour 24

Study Arms (2)

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.

Other: Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate

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).

Other: Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate

Interventions

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

Sodium bicarbonate; Sodium chloride (NaCl)

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patients with significant leaks \> 20% around the endotracheal tube
• Patients receiving spontaneous ventilation (inspiratory support, NIV, etc.)
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Florent BAUDIN

Bron, France, 69500, France

Location

MeSH Terms

Interventions

Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Florent BAUDIN, Pr

CONTACT

04 72 12 97 05; florent.baudin@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): April 20, 2028
• Study Completion (Estimated): July 20, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

FR (1)