Меню
Идёт набор NCT07073976

Evaluation of Right Ventricular Function to Predict Weaning Success in the Intensive Care Unit

Наблюдательное Weaning Failure of Mechanical Ventilation

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: Transthoracic Echocardiography (TTE).
Кому может быть актуально
Состояния в реестре: Weaning Failure of Mechanical Ventilation. Базовые параметры: от 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 →
Официальное название

Evaluation of Right Ventricular Function to Predict Weaning Success in the Intensive Care Unit: A Prospective Observational Study

Обзор

The goal of this prospective observational study is to evaluate whether right ventricular (RV) function parameters assessed via transthoracic echocardiography (TTE) can predict weaning success in adult intensive care unit (ICU) patients who are mechanically ventilated. The main questions it aims to answer are: Can the TAPSE (Tricuspid Annular Plane Systolic Excursion) value predict successful extubation? Do other right heart parameters (tricuspid S', RV-FAC, right atrial area, pulmonary valve acceleration time) provide additional prognostic value for weaning outcomes? Participants will: Be adult ICU patients planned for weaning from mechanical ventilation. Undergo transthoracic echocardiography within 2 hours after meeting clinical weaning criteria. Have the following echocardiographic parameters measured: TAPSE, tricuspid S', RV-FAC, right atrial area, and pulmonary valve acceleration time. Be monitored for 24 hours after extubation to assess weaning success (defined as no need for reintubation, non-invasive ventilation, or high-flow oxygen support).

Подробное описание

This is a prospective, observational, single-center study designed to investigate whether transthoracic echocardiographic (TTE) assessment of right ventricular function can predict weaning success in mechanically ventilated adult ICU patients. The primary objective is to determine the prognostic value of TAPSE (Tricuspid Annular Plane Systolic Excursion) in forecasting successful extubation.

Secondary objectives include the evaluation of additional echocardiographic parameters such as tricuspid annular systolic velocity (S'), right ventricular fractional area change (RV-FAC), right atrial area, and pulmonary valve acceleration time (PVAT). These parameters will be measured via bedside TTE within 2 hours after patients meet clinical weaning criteria and are hemodynamically stable.

All participants will be monitored for 24 hours after extubation. Weaning success is defined as the ability to sustain spontaneous breathing without the need for reintubation, non-invasive ventilation, or high-flow oxygen therapy during this period.

Data collection will include:

Echocardiographic measurements: TAPSE, tricuspid S', RV-FAC, right atrial area, and PVAT.

Demographic and clinical data: age, sex, BMI, ICU admission diagnosis, APACHE II and SOFA scores, ventilation settings, and duration of mechanical ventilation.

Post-extubation follow-up: reintubation, non-invasive ventilation or high-flow oxygen use, SpO₂ values, blood gas analysis, and vital signs.

This study does not involve any interventions beyond standard care. Echocardiography is routinely performed in ICU settings and poses no additional risk to participants.

The results may support the integration of right heart function assessment into routine ICU weaning protocols and improve clinical decision-making by reducing the incidence of weaning failure and associated complications.

Вмешательства

  • Диагностический тест Transthoracic Echocardiography (TTE)
    Non-invasive ultrasound imaging of the heart to evaluate right ventricular and right atrial function using parameters such as TAPSE, tricuspid S', RV-FAC, right atrial area, and pulmonary valve acceleration time. TTE will be performed once within 2 hours prior to extubation decision as part of routine care.

Первичные конечные точки

  • Discriminative Ability of TAPSE for Predicting Weaning Success [Срок оценки: Within 24 hours after extubation]
Вторичные конечные точки (4)
  • Discriminative Ability of RV-FAC in Predicting Weaning Success [Срок оценки: Within 24 hours after extubation]
  • Discriminative Ability of Tricuspid S' Velocity in Predicting Weaning Success [Срок оценки: Within 24 hours after extubation]
  • Correlation of Right Atrial Area With Weaning Outcome [Срок оценки: Within 24 hours after extubation]
  • Correlation of Pulmonary Valve Acceleration Time with Predicting Weaning Success [Срок оценки: Within 24 hours after extubation]

Критерии участия

Критерии включения

  • Receiving invasive mechanical ventilation in the ICU
  • Planned extubation (weaning) according to standard clinical criteria
  • Hemodynamically stable at the time of transthoracic echocardiography (TTE)
  • Ability to undergo echocardiographic assessment within 2 hours prior to extubation
  • Informed consent obtained from patient or legal representative

Критерии исключения

  • Known severe tricuspid valve disease or congenital heart disease
  • Moderate to severe pericardial effusion or cardiac tamponade
  • Inadequate acoustic window for transthoracic echocardiography
  • Patients requiring urgent or unplanned extubation
  • Use of extracorporeal life support (e.g., ECMO) at the time of assessment
  • Known pulmonary embolism or acute cor pulmonale
  • Pregnancy

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital — Istanbul

Идентификаторы

NCT: NCT07073976 · Weaning-Right Heart

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗