Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07532811

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Respiratory Failure

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florent BAUDIN

Bron, France, 69500

Location status: Recruiting

Location contact

Florent BAUDIN, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Proportion of patients with pulmonary perfusion acquisition consider as valid

    Time frame: Hour 0 ; Between Hour 4 and Hour 6

    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.

Secondary outcomes

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

    Time frame: Between Hour 4 and Hour 6

    Increase in the volume and/or concentration of the saline solution due to insufficient signal detection during the first injection (Group 1).

  2. Proportion of respiratory acquisition failures explained by breathing movements

    Time frame: Hour 0 ; Between Hour 4 and Hour 6

    Data acquisition failure related to variations in the airway pressure waveform recorded by the software.

  3. Distribution of pulmonary perfusion

    Time frame: Hour 0 ; Between Hour 4 and Hour 6

    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).

  4. Natremia variation after injection

    Time frame: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7

    Serum sodium concentration (mmol/L) measured before and after injection, with calculation of absolute (mmol/L) and relative (%) changes.

  5. Natremia variation at day one

    Time frame: Hour 0 ; Hour 24

    Serum sodium concentration (mmol/L) measured at baseline and on day 1, with calculation of absolute (mmol/L) and relative (%) changes from baseline.

  6. Heart rate variation

    Time frame: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7

    Heart rate (beats/min) measured before and after saline solution injection, with calculation of absolute (beats/min) and relative (%) changes

  7. Blood pressure variation

    Time frame: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7

    Systolic, diastolic, and mean arterial blood pressure measured before and after saline solution injection, with calculation of absolute (mmHg) and relative (%) changes.

  8. Significant hemodynamic events

    Time frame: Through study completion, an average of 24 hours

    Any change in heart rate or systolic blood pressure > 15% from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Florent BAUDIN, Pr

CONTACT

[email protected]

04 72 12 97 05

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PELUCHE 2

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 16, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.