Идёт набор NCT05898269

Fluid Responsiveness Prediction During Prone Position

Без фазы С лечением 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: Trendelenburg maneuver, End-expiratory occlusion test (EE OCC), End-expiratory and end-inspiratory occlusion test (EI OCC), Tidal volume challenge.
Кому может быть актуально: Состояния в реестре: Acute Respiratory Distress Syndrome. 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

Evaluation of the Diagnostic Performance of 4 Dynamic Tests Evaluating Preload Dependence in Patients With Acute Respiratory Distress Syndrome in the Prone Position

Обзор

Predicting fluid responsiveness is primordial when caring for patients with circulatory shock as it allows correction of preload-dependent low cardiac output states, while preserving patients of the deleterious effects of excessive fluid resuscitation. Patients with severe acute respiratory distress syndrome (ARDS) treated with prone positioning (PP) are a specific subset of patients, as 1) they frequently present with shock; 2) excessive fluid administration may lead to respiratory worsening due to increased hydrostatic oedema with potential subsequent worse clinical outcome; and 3) all available dynamic tests evaluating fluid responsiveness can only be performed in patients in the supine condition (which in the case of severe ARDS patients in PP occurs only for 8h over 24h). These elements warrant the development of specific tests allowing the clinician to predict fluid responsiveness with enough exactitude when caring for these patients. We hypothesize that there exists diagnostic heterogeneity in the predictive performance of 4 clinical tests to identify fluid responsiveness in ARDS patients in PP. For the matter of this study, these 4 tests are the Trendelenburg maneuver, the end-expiratory occlusion test, the end-expiratory occlusion test associated with the end-inspiratory occlusion test, and the tidal volume challenge. The diagnostic reference of the study will be the relative change in cardiac index measured by transpulmonary thermodilution before and after a 500 ml fluid bolus, and will allow the adjudication of patients as being fluid responsive or not. The primary objective of the study is to determine the area under the ROC curve of each of the 4 tests, with their respective 95% confidence interval. All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. Patients will only participate once. The expected duration of study participation is 30 minutes maximum.

Вмешательства

Диагностический тест Trendelenburg maneuver
Bed tilting from the +13° position to the -13° position for 60 seconds. Evaluator: relative change in continuous cardiac index between baseline, and the highest value observed during the maneuver
Диагностический тест End-expiratory occlusion test (EE OCC)
End-expiratory pause performed on the ventilator, and maintained for 15 seconds. Evaluator: relative change in continuous cardiac index between baseline, and the value observed in the last 5 seconds of the respiratory pause
Диагностический тест End-expiratory and end-inspiratory occlusion test (EI OCC)
End-inspiratory pause performed on the ventilator, and maintained for 15 seconds. Evaluator: relative change in continuous cardiac index between baseline, and the value observed in the last 5 seconds of the respiratory pause. The evaluator is calculated as the sum of the relative change in cardiac index observed during the end-expiratory pause and that of the end-inspiratory pause. Hence, for this test, the evaluator will be coupled with that of intervention 2 (end-expiratory occlusion test).
Диагностический тест Tidal volume challenge
Increase in tidal volume set on the ventilator from 6 ml.kg-1 of predicted body weight, to 8 ml.kg-1 for 60 seconds. Evaluator: difference in the pulse pressure variation measured at 6 ml.kg-1 and at 8 ml.kg-1.
Диагностический тест Fluid bolus (reference diagnostic method)
After the 4 tests, the patient will receive a 500-ml fluid bolus of crystalloids in less than 15 minutes. Evaluator (reference method): cardiac index measured by transpulmonary thermodilution before and immediately after the fluid bolus. Patients with a relative change in cardiac index \> 15% will be identified as being fluid responders, and the others as non-responders.

Первичные конечные точки

Area under the ROC curve (AUROC) of the evaluated tests. [Срок оценки: 30 minutes]

Вторичные конечные точки (4)

Comparison of diagnostic performance of the evaluated tests. [Срок оценки: 30 minutes]
Diagnostic performance metrics of each test [Срок оценки: 30 minutes]
Weighted diagnostic performance of each test [Срок оценки: 30 minutes]
Grey zone area of the optimal diagnostic threshold of each test [Срок оценки: 30 minutes]

Критерии участия

Критерии включения

adult patient (including patient under protective measures/wardship)
with ARDS as defined by the Berlin criteria
in the prone position as per international guidelines
with a calibrated continuous cardiac output monitoring device
with a clinical indication for a fluid bolus as prescribed by the clinician in charge, and fulfilling at least 2 clinical criteria: mottles, tachycardia, hypotension, drop in cardiac output, oliguria, high arterial lactate concentration, or any other detailed criterion
with no respiratory efforts