Идёт набор NCT06923267

Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials

Без фазы С лечением Weaning Invasive Mechanical Ventilation Weaning-induced Pulmonary Edema Weaning Failure of Mechanical Ventilation Spontaneous Breathing Test

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: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial, Pressure Support Spontaneous Breathing trial, Humidified High Flow Spontaneous Breathing Trial.
Кому может быть актуально: Состояния в реестре: Weaning Invasive Mechanical Ventilation, Weaning-induced Pulmonary Edema, Weaning Failure of Mechanical Ventilation, Spontaneous Breathing Test. 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: Франция
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

Ultrasound Evaluation of Cardiac Function During Three Spontaneous Breathing Trials in Intensive Care Unit : A Prospective Interventional Study

Обзор

The goal of this clinical trial is to evaluate the evolution of a cardiac ultrasound index (E/E') during 3 spontaneous breathing trials in Intensive Care Unit (ICU) adults (over 18 years) patients at risk for weaning failure. The main objective is to find out which spontaneous breathing trial is the least demanding in terms of heart work. Investigators will compare 3 consecutive spontaneous breathing trials in a random order to see if one is superior to the others. Participants will not have to perform any specific procedure apart from breathing without respiratory support during the spontaneous breathing trial. During these trials, the investigator will perform cardiac ultrasound measurements.

Вмешательства

Диагностический тест No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing both the positive end-expiratory pressure (PEEP) and the pressure support to 0 cmH2O, for 15 minutes.
Диагностический тест Pressure Support Spontaneous Breathing trial
The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing the positive end-expiratory pressure (PEEP) to 0 cmH2O and the pressure support to 7 cmH2O, for 15 minutes. A 10-minute washout period is left before the start of the next SBT modality.
Диагностический тест Humidified High Flow Spontaneous Breathing Trial
The spontaneous breathing trial is carried out with humidified high flow ventilator mode set at 50 liters per minute for 15 minutes. The patient will be connected to the ventilator via a specific connector enabling the administration of humidified high flow. A 10-minute washout period is left before the start of the next SBT modality.

Первичные конечные точки

Ultrasonographic evaluation of cardio E/E' index during 3 randomly assigned cross-over spontaneous breathing trials. [Срок оценки: At the 5th minute from beginning of each spontaneous breathing trial (each breathing trial is 15 minutes)]

Критерии участия

Критерии включения

Intubated patient undergoing invasive mechanical ventilation for at least 24 hours and scheduled for a spontaneous breathing trial
Richmond Agitation Sedation Scale (RASS) between -1 and +1
Patient at high risk of re-intubation with at least one of the following criteria:

Underlying cardiac disease (left ventricular dysfunction with left ventricular ejection fraction ≤ 45%, documented ischemic heart disease, chronic atrial fibrillation, known history of cardiogenic pulmonary edema)
Underlying respiratory disease (COPD, Emphysema, bronchial dilatation, asthma, obesity/hypoventilation syndrome, restrictive lung disease)