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

NCT07532811 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-19

No results posted yet for this study

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

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 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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-13
Primary Completion
2028-05-13
Completion
2028-08-13

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07532811 on ClinicalTrials.gov