Evaluation of Perfusion and Ventilation Distribution in Children: a Pilot Study. (PELUCHE 2)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Other: Evaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florent BAUDIN, Pr; Phone Number: 04 72 12 97 05; Email: florent.baudin@chu-lyon.fr

Study Locations

• France
  • France
    • Bron, France, France, 69500
      • Recruiting
      • Florent BAUDIN
      • Principal Investigator: Florent BAUDIN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sodium chloride (NaCl); 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; 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
Experimental: Sodium bicarbonate; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2026
• Primary Completion (Estimated): May 13, 2028
• Study Completion (Estimated): August 13, 2028

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Electrical impedance tomography; Pediatric intensive care unit; Perfusion and ventilation distribution
• Additional Relevant MeSH Terms: Inorganic Chemicals; Sodium Compounds; Carbon Compounds, Inorganic; Carbonates; Carbonic Acid; Bicarbonates; Sodium Bicarbonate
• Other Study ID Numbers: 69HCL25_0492; 2025-A02466-43 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No