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Идёт набор NCT06051292

Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

Без фазы С лечением Pediatric Acute Respiratory Distress Syndrome (PARDS) Acute Respiratory Failure Acute Respiratory Distress Syndrome

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: Fast method, Conventional method.
Кому может быть актуально
Состояния в реестре: Pediatric Acute Respiratory Distress Syndrome (PARDS), Acute Respiratory Failure, Acute Respiratory Distress Syndrome. Базовые параметры: 1 мес. — 18 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement

Обзор

Mechanical ventilation is a critical intervention in the management of pediatric patients with respiratory distress. During this process, accurate measurement of transpulmonary pressure (PL) is essential to ensure the safety and efficacy of ventilation. PL is defined as the difference between alveolar pressure (Palv) and pleural pressure (Ppl). While the direct measurement of Ppl is possible, it poses a risk to tissue integrity. Thus, the primary surrogate for Ppl measurement today is esophageal pressure (Pes). However, the measurement of Pes is not without challenges. This abstract outlines the pitfalls associated with Pes measurement, emphasizing the importance of employing well-defined procedures to mitigate potential errors. These errors can range from underestimation of Pes due to underfilled catheters to overestimation resulting from overfilled catheters. To address these challenges and optimize Pes measurement, various methods have been proposed for titrating the filling volume of the esophageal catheter. In this study, investigators aim to assess a faster decremental filling method and compare it to the traditionally accepted Mojoli method in the context of pediatric patients. This research seeks to enhance the intensivists' understanding of the most efficient and accurate approach to Pes measurement during mechanical ventilation in the pediatric population, ultimately contributing to improved patient care and outcomes

Вмешательства

  • Другое Fast method
    Fast decremental catheter volume titration will be applied and optimal filling volume will be determined according to the measurements
  • Другое Conventional method
    Conventional catheter volume titration will be applied and optimal filling volume will be determined according to the measurements

Первичные конечные точки

  • Optimal catheter filling volume [Срок оценки: up 1 hour after catheter placement]
Вторичные конечные точки (2)
  • Transpulmonary driving pressure [Срок оценки: up 1 hour after catheter placement]
  • Time [Срок оценки: up 1 hour after catheter placement]

Критерии участия

Критерии включения

  • Pediatric patients between 1 months and 18 years
  • Patients need mechanical ventilation support without modification of ventilation settings within the upcoming 2 hours
  • Informed consent was signed by next of kin
  • Requiring esophageal catheter application

Критерии исключения

  • Patients eligible for extubation or modification of ventilation settings within the upcoming 2 hours
  • Patient included in another interventional study in the last 30 days
  • Patients unable to undergo esophageal catheter insertion due to congenital or acquired pathologies
  • Patient included in another interventional research study under consent
  • Patient already enrolled in the present study in a previous episode of acute respiratory failure

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 4 центра
  • Aydin Obstetric and pediatrics Hospital — Aydin
  • Erzurum Regional Research and Training Hospital — Erzurum
  • Cam Sakura Research and Training Hospital — Istanbul
  • The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Trai — Izmir

Публикации

  • Mojoli F, Chiumello D, Pozzi M, Algieri I, Bianzina S, Luoni S, Volta CA, Braschi A, Brochard L. Esophageal pressure measurements under different conditions of intrathoracic pressure. An in vitro study of second generation balloon catheters. Minerva Anestesiol. 2015 Aug;81(8):855-64. Epub 2015 Jan 30. PMID 25634481
  • Hotz JC, Sodetani CT, Van Steenbergen J, Khemani RG, Deakers TW, Newth CJ. Measurements Obtained From Esophageal Balloon Catheters Are Affected by the Esophageal Balloon Filling Volume in Children With ARDS. Respir Care. 2018 Feb;63(2):177-186. doi: 10.4187/respcare.05685. Epub 2017 Oct 31. PMID 29089460
  • Mojoli F, Iotti GA, Torriglia F, Pozzi M, Volta CA, Bianzina S, Braschi A, Brochard L. In vivo calibration of esophageal pressure in the mechanically ventilated patient makes measurements reliable. Crit Care. 2016 Apr 11;20:98. doi: 10.1186/s13054-016-1278-5. PMID 27063290

Идентификаторы

NCT: NCT06051292 · 02020395

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗