Набор скоро начнётся NCT07666880

Hemodynamic Impact of the Spontaneous Ventilation Test in Patients at Risk of Weaning Pulmonary Oedema

Без фазы С лечением Weaning-induced Pulmonary Edema

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: T-piece SBT, PS-ZEEP SBT.
Кому может быть актуально: Состояния в реестре: Weaning-induced Pulmonary Edema. 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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Обзор

Weaning-induced pulmonary edema (WIPE) from the ventilator is a frequent cause of extubation failure or delay, which prolongs the duration of invasive mechanical ventilation and the associated morbidity and mortality. WIPE is a very frequent cause of extubation failure in at-risk patients. A spontaneous breathing trial (SBT) is performed before extubating a patient, either by disconnecting the patient from the ventilator (T-piece SBT) or by setting the ventilator to spontaneous breathing mode with pressure support at 7 cm H2O and zero positive end-expiratory pressure (PS-ZEEP SBT). There is currently no recommendation regarding which SBT modality should be used, particularly in patients at risk of WIPE. The hemodynamic changes induced by the SBT can lead to WIPE, which typically develops within minutes of the SBT onset. The hypothesis being tested is that, by altering intrathoracic pressure during the patient's inspiration (negative pressure), the T-piece SBT leads to a greater increase in left ventricular filling pressures compared to the PS-ZEEP SBT.

Вмешательства

Процедура T-piece SBT
T-piece SBT will be evaluated first and PS-ZEEP SBT in a second time. If the first SBT fails, regardless of the modality used or the cause of failure, the second SBT will not be performed. The patient will then be managed according to the participating centers' standard of care (treatment guided by the main mechanism of WIPE identified by echocardiography). The two SBTs will be separated by at least 6 hours, during which no therapeutic changes will be made (in case of success at the first SBT).
Процедура PS-ZEEP SBT
In this arm, PS-ZEEP SBT will be evaluated first and T-piece SBT ina second time. If the first SBT fails, regardless of the modality used or the cause of failure, the second SBT will not be performed. The patient will then be managed according to the participating centers' standard of care (treatment guided by the main mechanism of WIPE identified by echocardiography). The two SBTs will be separated by at least 6 hours, during which no therapeutic changes will be made (in case of success at the

Первичные конечные точки

E/e' ratio [Срок оценки: Day 1]

Вторичные конечные точки (12)

Absolute change in the averaged E/e' ratio [Срок оценки: Day1]
Absolute change in arterial pressure [Срок оценки: day 1]
Relative change in arterial pressure [Срок оценки: Day 1]
Number of WIPE cases [Срок оценки: Day 1]
Proportion of WIPE cases [Срок оценки: Day 1]
Number of SBT interruptions [Срок оценки: Day 1]
Absolute change in peak velocity of the mitral E wave [Срок оценки: Day 1]
Relative change in peak velocity of the mitral E wave [Срок оценки: Day 1]
Relative change in peak velocity of the mitral e' wave [Срок оценки: Day 1]
Absolute change in peak velocity of the mitral e' wave [Срок оценки: Day 1]
Absolute change in peak velocity of tricuspid regurgitation [Срок оценки: Day 1]
Relative change in peak velocity of tricuspid regurgitation [Срок оценки: Day 1]

Критерии участия

Критерии включения

Adult patient (> 18 years) on invasive mechanical ventilation in the ICU for more than 48 hours
In the ventilator weaning phase with a first SBT planned
At risk of WIPE: age over 65 years and/or any type of heart disease and/or chronic respiratory failure and/or obesity