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Идёт набор NCT06037083

Post-Extubation Assessment of Clinical Stability in ELBW Infants

— Наблюдательное Extremely Low Birth Weight 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: Oxygen saturation probe, Near infrared spectroscopy sensors, Electrical impedance tomography.
Кому может быть актуально
Состояния в реестре: Extremely Low Birth Weight Infants. Базовые параметры: до 28 Weeks · 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
Канада
Следующий шаг
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Официальное название

Post-Extubation Assessment of Clinical Stability in Extremely Preterm Infants: The PEACE Feasibility Study

Обзор

This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation (via cerebral and splanchnic near-infrared spectroscopy), and regional ventilation (via electrical impedance tomography) from 20 extremely low birth weight infants at high-risk of reintubation.

Подробное описание

The primary aim of this proof-of-concept study is to evaluate the feasibility and acceptance of a monitoring system that integrates clinical data and biomedical signals from multiple modalities in a cohort of extremely preterm infants at high-risk of clinical instability on non-invasive respiratory support.

Secondary aims will be to longitudinally describe peripheral oxygen saturation, cerebral oxygen saturation, splanchnic oxygen saturation and regional lung ventilation in extremely low birth weight infants with or without reintubation during the 7 days post extubation.

The application of this multimodal monitoring approach using both clinical and physiological data during the postextubation period will help by making the assessment of clinical stability more comprehensive, more objective, more accurate, more standardized, and more reflective of important end-organ function. Thus, the proposed multimodal monitoring could lead to more informed decisions about reintubation and more individualized treatment plans during this critical period, hence potentially leading to better outcomes.

Вмешательства

  • Устройство Oxygen saturation probe
    The high-accuracy oxygen saturation signal will be continuously acquired for 168 hours post extubation from a separate pulse oximeter (Radical-7®, Masimo ROOT platform, MasimoCorp, Irvine, LA).
  • Устройство Near infrared spectroscopy sensors
    The cerebral and splanchnic regional oxygen saturation signals will be acquired continuously for 168h post extubation using two near infrared spectroscopy sensors (Masimo ROOT platform, MasimoCorp, Irvine, LA), one placed on the forehead for cerebral oxygenation and one on the abdomen (for splanchnic oxygenation).
  • Устройство Electrical impedance tomography
    The regional lung ventilation will be measured using Electrical Impedance Tomography (TIMPEL, USA) at three time points: * From 1 hour pre-extubation to 2 hours post extubation (total 3 hours) * Between 24 and 48 hours post extubation (total 3 hours) * Between 72 and 96 hours post extubation (total 3 hours)

Первичные конечные точки

  • Recruitment rate [Срок оценки: 168 hours]
  • Consent rate [Срок оценки: 168 hours]
  • Acceptability of the multimodal monitoring approach [Срок оценки: 168 hours]
Вторичные конечные точки (4)
  • To describe longitudinal peripheral blood oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation [Срок оценки: 168 hours]
  • To describe longitudinal cerebral oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation [Срок оценки: 168 hours]
  • To describe longitudinal splanchnic oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation [Срок оценки: 168 hours]
  • To describe regional lung ventilation from the immediate pre-extubation period until 72-96 hours post-extubation. [Срок оценки: 96 hours]

Критерии участия

Критерии включения

  • Birth weight < 1000g and gestational age < 28+0 weeks,
  • Received mechanical ventilation within the first 72h of life,
  • Undergoing their first planned extubation within the first 6 weeks of life.

Критерии исключения

\- Congenital anomalies and congenital heart disorders.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 2 центра
  • Centre Hospitalier Universitaire Sainte-Justine — Montreal
  • McGill University Health Center — Montreal

Идентификаторы

NCT: NCT06037083 · 2023-8794

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗