Optimization of Respiratory Effort With Titrated Sedation in AHRF
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: AHRF. 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
- Италия
- 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
Optimization of Respiratory Effort With Titrated Sedation in Patients With Acute Hypoxemic Respiratory Failure - The OPTIREST Study
Обзор
Prospective, observational, monocentric study to assess the physiological effects of dexmedetomidine and remifentanil in spontaneously breathing patients with acute hypoxemic respiratory failure receiving high-flow nasal oxygen.
Подробное описание
Sedation in spontaneously breathing hypoxemic patients represents a critical physiological trade-off between lung protection and maintenance of adequate ventilation. While spontaneous breathing is generally encouraged to preserve diaphragm function and avoid invasive ventilation, excessive respiratory drive may promote patient self-inflicted lung injury (P-SILI) through increased inspiratory effort, elevated transpulmonary pressure swings, pendelluft phenomena, and regional stress amplification. Conversely, excessive sedation may suppress respiratory drive, resulting in hypoventilation, impaired gas exchange, and diaphragm disuse. Sedation therefore behaves as a double-edged sword, requiring careful titration to balance lung protection and adequate ventilation. Despite the widespread use of dexmedetomidine and remifentanil in this setting, limited information is available regarding their dose-dependent physiological effects on inspiratory effort, transpulmonary pressure, regional ventilation distribution, expiratory muscle recruitment, and lung stress. Current clinical practice relies mainly on symptom control (dyspnea, agitation, tachypnea) without direct assessment of the mechanical and regional effects of sedation on the injured lung; consequently, sedation strategies remain largely empirical and poorly standardized. The study aims to characterize the effects of sedation administered through Target-Controlled Infusion (TCI) on respiratory mechanics and regional lung behavior in spontaneously breathing patients receiving high-flow nasal oxygen. By integrating esophageal pressure monitoring and electrical impedance tomography, the effects of increasing effect-site concentrations of dexmedetomidine or remifentanil on inspiratory effort and its regional consequences will be investigated.
Первичные конечные точки
- Inspiratory effort, expressed in cmH2O [Срок оценки: During procedure]
Вторичные конечные точки (12)
- Dyspnea [Срок оценки: During procedure]
- Discomfort [Срок оценки: During procedure]
- PaO2/FiO2 ratio [Срок оценки: During procedure]
- Respiratory rate [Срок оценки: During procedure]
- Recuitment of expiratory muscles, expressed in cmH2O of gastric pressure [Срок оценки: During procedure]
- Tidal volume distribution [Срок оценки: During procedure]
- End-expiratory lung volume [Срок оценки: During procedure]
- Regional End-expiratory lung volume [Срок оценки: During procedure]
- Dynamic transpulmonary driving pressure [Срок оценки: During procedure]
- Global impedance-derived lung dynamic strain [Срок оценки: During procedure]
- Regional impedance-derived lung dynamic strain [Срок оценки: During procedure]
- Pendelluft [Срок оценки: During procedure]
Критерии участия
Критерии включения
- Age ≥18 years
- PaO2/FiO2 ratio ≤ 200;
- PaCO2 < 45 mmHg;
- At least one symptom prompting the use of sedative-analgesic drugs according to the prescription of the attending physician: dyspnea and/or discomfort equal of greater than 4/10 (Visual Analog Scale - VAS), respiratory rate equal or greater than 25 breaths per minute, PaCO2<35 mmHg, pain (Numeric Rating Scale ≥ 4 or Behavioral Pain Scale - Non-Intubated ≥ 4);
- Informed consent signature.
Критерии исключения
- Pregnancy;
- Exacerbation of asthma or chronic obstructive pulmonary disease;
- Chronic lung disease, requiring oxygen therapy at home;
- Cardiogenic pulmonary oedema;
- Hemodynamic instability (systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg) and/or lactic acidosis (lactate >5 mmol/L) and/or clinically diagnosed shock;
- Metabolic acidosis (pH <7.30 with normal or hypocarbia);
- Glasgow Coma Scale <13;
- Contraindications to esophageal balloon and/or EIT placement.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Италия · 1 центр
- Fondazione Policlinico Universitario A.Gemelli IRCCS — Roma
Идентификаторы
NCT: NCT07679932 · 27387-1