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Идёт набор NCT07595926

Height Measurement Procedures Influence the Risk of Ventilator-induced Lung Injury in ARDS

Без фазы С лечением Acute Respiratory Distress Syndrome Ventilator-Induced Lung Injury Tidal Volume Predicted Body Weight

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: height measured.
Кому может быть актуально
Состояния в реестре: Acute Respiratory Distress Syndrome, Ventilator-Induced Lung Injury, Tidal Volume, Predicted Body Weight. 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
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Обзор

Acute respiratory distress syndrome is characterized by heterogeneous lung injury, with dependent regions often collapsed and non-dependent regions relatively well-aerated, forming the so called "baby lung." Mechanical ventilation, while essential, can induce additional lung injury (VILI) via overdistension (baro/volutrauma) or repetitive alveolar collapse (atelectrauma). Protective ventilation strategies with low tidal volumes (VT 6-8 mL/kg predicted body weight, PBW) reduce mortality, but their efficacy relies on accurate PBW estimation, which is derived from patient height. In critical care, height measurement is often challenging, and common methods such as visual estimation or tape measurement can be inaccurate, leading to inappropriate VT settings and increased risk of lung stress and VILI. Alternative methods, including heel-to-knee distance and laser measurement, may offer more precise PBW estimation, yet their impact on lung mechanics in ARDS remains unexplored. This study addresses the knowledge gap by evaluating whether differences in height measurement methods significantly affect lung stress, tidal volume distribution, and ventilatory mechanics in ARDS patients. Patients' heights will be measured using five methods (stadiometer, visual, tape, laser, heel-to knee). Corresponding PBW and tidal volumes (VT = 6 mL/kg PBW) will be calculated and applied in randomized order, each for 30 minutes. Lung stress, ventilatory mechanics, gas exchange, and regional ventilation distribution will be assessed for each VT setting, preceded by a short alveolar recruitment maneuver. During the study, continuous monitoring of hemodynamics and oxygenation will be performed. Ventilatory parameters including plateau pressure, driving pressure, and transpulmonary pressures will be recorded. Electrical impedance tomography will assess regional tidal volume distribution. Each patient's participation is limited to approximately two hours with no further follow-up.

Вмешательства

  • Другое height measured
    Patients with ARDS will have their height measured using five different methods: stadiometer (reference), visual estimation, measuring tape, infrared laser, and heel-to-knee distance. For each height, the predicted body weight (PBW) and corresponding tidal volume (VT = 6 mL/kg PBW) will be calculated and applied in a randomized order, each for 30 minutes. During each VT period, lung stress (end-inspiratory transpulmonary pressure), ventilatory mechanics, gas exchange, and regional ventilation d

Первичные конечные точки

  • Pulmonary stress [Срок оценки: one day]
Вторичные конечные точки (5)
  • measured height variation [Срок оценки: one day]
  • predicted body weight variation [Срок оценки: one day]
  • tidal volume variation [Срок оценки: one day]
  • Transpulmonary pressures at end-expiratory [Срок оценки: one day]
  • Transpulmonary pressures at end-inspiratory intervals. [Срок оценки: one day]

Критерии участия

Критерии включения

  • Adult patient
  • Mechanical ventilation on volumetric mode
  • Sedated and curarized patient
  • Diagnosis of ARDS according to the Berlin criteria
  • Diagnosis of ARDS < 48 hours
  • Signed informed consent
  • Affiliation with a social security or health insurance scheme

Критерии исключения

  • Patient opposing the use of his/her data for research purposes.
  • Contraindication to placement of an esophageal balloon catheter (e.g., esophageal fistula, esophageal varices).
  • Contraindication to strict supine positioning for height measurement (e.g., proven or suspected intracranial hypertension with intracranial pressure >18 mmHg).
  • Impossibility of measuring height with the reference method (stadiometer) due to deformity or amputation of both lower limbs.
  • Patient under guardianship or curatorship, or deprived of liberty.
  • Pregnant or postpartum patient, or patient currently breastfeeding.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • CHU Amiens — Amiens

Идентификаторы

NCT: NCT07595926 · PI2026_843_0061

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗