Electrical Impedance Tomography for Identification of Optimal Positive End-expiratory Pressure in Newborn Infants
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Electrical impedance tomography (EIT), Forced oscillation technique (FOT), Saturation oxygenation pressure index (SOPI).
- Кому может быть актуально
- Состояния в реестре: Positive End-expiratory Pressure (PEEP). Базовые параметры: 0 Days — 28 Days · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швейцария
- Следующий шаг
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Обзор
Electrical impedance tomography (EIT) enables assessment of regional lung ventilation at the bedside. EIT has been safely used in newborn infants to image intrathoracic lung volume patterns as early as from the first minute of life. This prospective single-centre observational study is to identify optimal PEEP in infants on respiratory support by measurements of EIT, FOT and SOPI.
Подробное описание
Evidence-based guidelines on the optimal level of positive end-expiratory pressure (PEEP) in newborn infants on respiratory support do not exist. Furthermore, there is a lack of simple bed-side parameters to guide clinicians towards the optimal PEEP level. Nevertheless, PEEP requires individual adjustment to minimize ventilator induced lung injury (VILI), shorten the duration of mechanical ventilation and reduce respiratory long-term morbidity.
Potential techniques to assess optimal PEEP level in infants on respiratory support include electrical impedance tomography (EIT), the forced oscillation technique (FOT) and the saturation oxygenation pressure index (SOPI). EIT is a promising non-invasive technique that provides information on regional changes in lung aeration and ventilation inhomogeneity. FOT is used in mechanically ventilated or spontaneously breathing infants and provides information on reactance (Xrs) and resistance (Rrs) of the respiratory system. SOPI is a score calculated from the PEEP level, the amount of administered oxygen (FiO2) and the infant's peripheral oxyhaemoglobin saturation (SpO2). SOPI provides information on the ventilation to perfusion ratio dependent on the PEEP level. EIT, FOT and SOPI seem promising tools for identification of optimal PEEP in newborn infants on respiratory support. In particular, a combination of information on regional ventilation (by EIT), global lung mechanics (by FOT) and ventilation to perfusion ratio (by SOPI) will improve the understanding of optimal PEEP and may reduce long-term respiratory sequelae.
This prospective single-centre observational study is to identify optimal PEEP in infants on respiratory support by measurements of EIT, FOT and SOPI. Measurements are performed once daily during the first three days on respiratory support and are repeated in weekly intervals if the infant remains mechanically ventilated. An additional measurement is planned after extubation.
Вмешательства
- Диагностический тест Electrical impedance tomography (EIT)
EIT is the measurement of impedance changes of the lung against the flow of alternating electrical currents applied to the thorax. The signal of the electrodes is transmitted to a monitor, which enables real-time assessment of lung aeration and changes in lung volume. EIT is able to reconstruct impedance changes with a high temporal resolution and allows calculation of tidal volumes, relative stretch of lung tissue and areas of poor ventilation. Areas with impedance changes of \< 10 % of the max - Диагностический тест Forced oscillation technique (FOT)
FOT enables non-invasive assessment of lung mechanics using sound waves to inform about the respiratory impedance of the respiratory system (Zrs). Reactance of the respiratory system (Xrs) as part of Zrs is a surrogate measure of compliance of the respiratory system. Xrs was previously used to identify optimal PEEP level, i.e., the PEEP at highest compliance equivalent, in newborn infants using a setup requiring research-specific hardware and software. The FOT module integrated in the commercial - Диагностический тест Saturation oxygenation pressure index (SOPI)
SOPI is assessed non-invasively and calculated from standard monitoring parameters such as PEEP, fraction of inspired oxygen pressure (FiO2) and peripheral oxyhaemoglobin saturation (SpO2) (PEEP x FiO2 x 100) / SpO2). SOPI is used to provide information on ventilation to perfusion ratio dependent on PEEP level.
Первичные конечные точки
- Change in composite score consisting of proportionally weighted raw values of Silent Spaces, Xrs and SOPI (mechanical ventilation) [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
- Change in composite score consisting of proportionally weighted raw values of Silent Spaces and SOPI (non-invasive respiratory support) [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
- Change in Silent Spaces (areas of atelectasis as well as overdistension) [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
- Change in respiratory reactance (Xrs) (measure of compliance of the respiratory system) [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
- Change in Saturation oxygenation pressure index (SOPI) [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
Вторичные конечные точки (10)
- Change in Delta impedance (ΔZ) [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
- Change in centre of ventilation (CoV) [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
- Change in tidal volume (VT,EIT) [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
- Change in driving pressure of the respiratory system (Peak plateau pressure - PEEP) [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
- Change in resistance (Rrs) of the respiratory system [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
- Change in peak inspiratory pressure [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
- Change in tidal volume per kg body weight (VT/kg) [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
- Change in dynamic compliance [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
- Change in respiratory rate [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
- Change in transcutaneous CO2 pressure (tcpCO2) [Срок оценки: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
Критерии участия
Критерии включения
- 22+0 to 41+6 weeks' gestational age
- Requiring mechanical ventilation
- Written informed parental consent
Критерии исключения
- Major congenital malformations including lung and cardiac malformations
- Infants on high frequency oscillatory ventilation
- Lack of written informed parental consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Швейцария · 1 центр
- Department of Neonatology, University Children's Hospital Basel UKBB — Basel
Идентификаторы
NCT: NCT05612256 · 2022-00508; ks22Gerull