Меню
Набор скоро начнётся NCT07182539

VCV vs PRVC in Pediatric Anesthesia; an EIT- and LS-based Study

Без фазы С лечением Atelectasis

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: PRVC ventilation, VCV ventilation.
Кому может быть актуально
Состояния в реестре: Atelectasis. Базовые параметры: 3 лет — 10 лет · 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Atelectasis in Pediatric Anesthesia: A Randomized Observational Study Comparing Volume-Controlled and Pressure-Regulated Volume Control Ventilation Via Lung Ultrasound and Electrical Impedance Tomography

Обзор

The primary objective of this study is to evaluate and compare the incidence and severity of intraoperative pulmonary atelectasis, measured by Lung Ultrasound Score (LUS) and EIT (Electrical Impedance Tomography), between two different modes of mechanical ventilation: Volume Control Ventilation (VCV) and Pressure Regulated Volume Control (PRVC/PCV-VG)

Подробное описание

Background Mechanical ventilation is often required in pediatric anesthesia. However, the optimal intraoperative ventilatory strategy for pediatric patients remains a matter of debate, with no definitive consensus to date. Among conventional modes, Pressure-Controlled Ventilation (PCV) is time-triggered, pressure-limited, time cycled; set parameters include peak inspiratory pressure (PIP), inspiratory time (Ti) and respiratory rate (RR). Tidal Volume (TV) is a dependent variable. With the constant pressure throughout inspiration, PCV is thought to provide the maximum inspiratory pressure for the entire inspiratory-time favoring lung recruitment1.

In contrast, Volume-Controlled ventilation (VCV) delivers the preset TV, and the PIP is dependent on the respiratory mechanics of the patient. VCV has the advantage of certain TV delivery, while PCV has the advantage of not exceeding the set PIP1.

Both have limitations and to overcome the inherent compromises of traditional modes, modern ventilation modes such as Pressure Regulated Volume Control (PRVC) have been developed. These modes are designed to combine the benefits of VCV and PCV. They use a pressure-controlled flow and ventilation application approach, integrated with digital feedback mechanisms that continuously monitor the applied tidal volume, targeting a fixed tidal volume. PRVC allows the ventilator to measure the patient's lung compliance on a breath-to-breath basis and determine the pressure required to be given for the set Ti to achieve the set tidal volume. As a result, the ventilator can deliver a square wave pressure waveform like PCV but also ensure that a constant tidal volume is delivered to the patient like VCV.

Regardless of the ventilation strategy, general anesthesia inevitably induces atelectasis2, due to different mechanisms such as: shift of the diaphragm towards the thorax thus causing compressions of some lung areas, surfactant alteration due to inhalational anaesthetics, high inspired fractions of oxygen (FiO2) which are reabsorbed from the alveoli into the bloodstream causing reduction of the alveolar size3. These effects are demonstrable both immediately after induction and at the endo of surgery.

Children are particularly vulnerable to anaesthesia-induced atelectasis, due to the relatively higher compliant chest wall and the presence of diaphragmatic compression by large abdominal organs4. The clinical consequences of atelectasis are significant and include increased intrapulmonary shunt (blood passing through the lungs without being oxygenated), perioperative desaturation, higher risk of pneumonia, and a broader spectrum of postoperative pulmonary complications (PPCs)5. Given the peculiarities that predispose paediatric patients to atelectasis, they cannot be considered simply as miniature adults; their unique physiology requires tailored protective ventilation strategies. This highlights the urgency of identifying optimal ventilatory modes capable of minimizing atelectasis in this vulnerable population Since the best ventilatory strategy to avoid atelectasis is not defined currently, with the present randomized clinical trial the investigators aim to compare the effects of two ventilatory modes (VCV and PRVC) at same settings in terms of tidal volume, PEEP, FiO2, on atelectasis as described by lung ultrasound and EIT. The investigators hypnotized that PRVC (combining pressure control with guaranteed tidal volume) reduces atelectasis severity compared to VCV, as measured by LUS and EIT.

Вмешательства

  • Другое PRVC ventilation
    Ventilation in PRVC mode.
  • Другое VCV ventilation
    Ventilation in VCV mode.

Первичные конечные точки

  • Atelectasis at lung ultrasound [Срок оценки: From baseline to recovery in post-anesthesia care unit]
  • Atelectasis [Срок оценки: From baseline to recovery in post-anesthesia care unit]
Вторичные конечные точки (5)
  • Regional distribution of ventilation and lung homogeneity [Срок оценки: From baseline to recovery in post-anesthesia care unit]
  • Peak Inspiratory Pressure [Срок оценки: From baseline to recovery in post-anesthesia care unit]
  • Plateau Pressure [Срок оценки: From baseline to recovery in post-anesthesia care unit]
  • Static Respiratory System Compliance [Срок оценки: From baseline to recovery in post-anesthesia care unit]
  • Dynamic Respiratory System Compliance [Срок оценки: From baseline to recovery in post-anesthesia care unit]

Критерии участия

Критерии включения

  • Patients requiring intraoperative mechanical ventilation via endotracheal intubation
  • Written informed consent obtained from parents or legal guardians. For children capable of understanding, assent will also be obtained based on age and cognitive ability.
  • ASA (American Society of Anesthesiologists) physical status I-II

Критерии исключения

  • Patients with significant pre-existing lung disease (e.g., cystic fibrosis, severe bronchopulmonary dysplasia, severe uncontrolled asthma, neuromuscular disease with respiratory compromise).
  • Patients with complex congenital heart disease or significant hemodynamic instability.
  • Patients undergoing thoracic surgery or procedures that could significantly alter lung mechanics (e.g., pre-existing pneumothorax).
  • Refusal of parents/guardians or patient to participate in the study.
  • History of previous intrathoracic procedure.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Италия · 1 центр
  • Vittore Buzzi Children's Hospital — Milan

Публикации

  • Camporesi A, Roveri G, Vetrugno L, Buonsenso D, De Giorgis V, Costanzo S, Pierucci UM, Pelizzo G. Lung ultrasound assessment of atelectasis following different anesthesia induction techniques in pediatric patients: a propensity score-matched, observational study. J Anesth Analg Crit Care. 2024 Oct 5;4(1):69. doi: 10.1186/s44158-024-00206-x. PMID 39369249
  • Frerichs I, Schiffmann H, Hahn G, Hellige G. Non-invasive radiation-free monitoring of regional lung ventilation in critically ill infants. Intensive Care Med. 2001 Aug;27(8):1385-94. doi: 10.1007/s001340101021. PMID 11511953
  • Kim YS, Won YJ, Lee DK, Lim BG, Kim H, Lee IO, Yun JH, Kong MH. Lung ultrasound score-based perioperative assessment of pressure-controlled ventilation-volume guaranteed or volume-controlled ventilation in geriatrics: a prospective randomized controlled trial. Clin Interv Aging. 2019 Jul 18;14:1319-1329. doi: 10.2147/CIA.S212334. eCollection 2019. PMID 31409981
  • Bauer M, Opitz A, Filser J, Jansen H, Meffert RH, Germer CT, Roewer N, Muellenbach RM, Kredel M. Perioperative redistribution of regional ventilation and pulmonary function: a prospective observational study in two cohorts of patients at risk for postoperative pulmonary complications. BMC Anesthesiol. 2019 Jul 27;19(1):132. doi: 10.1186/s12871-019-0805-8. PMID 31351452

Идентификаторы

NCT: NCT07182539 · VentiEIT_ped

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗