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

Официальное название

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

Обзор

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).

Вмешательства

• Другое 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 impedan

Первичные конечные точки

• Proportion of patients with pulmonary perfusion acquisition consider as valid [Срок оценки: Hour 0 ; Between Hour 4 and Hour 6]

Вторичные конечные точки (8)

• Proportion of patients requiring an increase in volume and/or concentration of saline solution [Срок оценки: Between Hour 4 and Hour 6]
• Proportion of respiratory acquisition failures explained by breathing movements [Срок оценки: Hour 0 ; Between Hour 4 and Hour 6]
• Distribution of pulmonary perfusion [Срок оценки: Hour 0 ; Between Hour 4 and Hour 6]
• Natremia variation after injection [Срок оценки: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7]
• Natremia variation at day one [Срок оценки: Hour 0 ; Hour 24]
• Heart rate variation [Срок оценки: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7]
• Blood pressure variation [Срок оценки: Hour 0 ; Hour 1 ; Between Hour 5 and Hour 7]
• Significant hemodynamic events [Срок оценки: Through study completion, an average of 24 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Florent BAUDIN — Bron

Идентификаторы

NCT: NCT07532811 · 69HCL25_0492 · 2025-A02466-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗