Идёт набор NCT06996834

Noninvasive Support Methods for Acute Respiratory Failure of Community-acquired Pneumonia

Без фазы С лечением Community-acquired Pneumonia Community-Acquired Infections

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: Non-Invasive ventilation (NIV), High Velocity Nasal Insufflation.
Кому может быть актуально: Состояния в реестре: Community-acquired Pneumonia, Community-Acquired Infections. 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: Египет
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

A Randomized Controlled Trial of High-Velocity Nasal Insufflation (HVNI) Versus Noninvasive Ventilation (NIV) for Acute Respiratory Failure of Community-Acquired Pneumonia (CAP).

Обзор

This randomized controlled trial aims to compare the efficacy and safety of high-velocity nasal insufflation (HVNI) versus standard noninvasive ventilation (NIV) in adult patients experiencing acute exacerbations of community-acquired pneumonia (CAP) accompanied by hypoxemic respiratory failure. The primary focus is on assessing treatment failure within 48 hours, defined as the need for intubation or death. Secondary outcomes include evaluations of gas exchange parameters, patient comfort levels, duration of ICU stay, and 28-day mortality rates.

Подробное описание

Community-acquired pneumonia (CAP) is a significant contributor to acute hypoxemic respiratory failure, often necessitating ventilatory support. Noninvasive ventilation (NIV) has been a conventional approach; however, it can be associated with patient discomfort and varying success rates. High-velocity nasal insufflation (HVNI) presents an alternative, delivering heated and humidified oxygen at high flow rates, which may improve oxygenation and patient tolerance.

This study is designed as a prospective, randomized, open-label, parallel-group trial involving 100 adult patients diagnosed with CAP-induced hypoxemic respiratory failure. Participants will be randomly assigned to receive either high-volume non-invasive ventilation (HVNI) or non-invasive ventilation (NIV). The primary endpoint is treatment failure within 48 hours post-randomization, characterized by the necessity for endotracheal intubation or mortality. Secondary endpoints encompass changes in arterial blood gas measurements, patient-reported comfort scores, length of ICU stay, and 28-day mortality rates.

By systematically comparing HVNI and NIV in this patient population, the study seeks to determine whether HVNI offers a viable and potentially superior alternative to traditional NIV methods in managing acute respiratory failure due to CAP.

Вмешательства

Устройство Non-Invasive ventilation (NIV)
Participants in this arm will receive noninvasive ventilation using bilevel positive airway pressure (BiPAP) delivered via a full-face mask to support ventilation in patients with acute hypoxemic respiratory failure due to CAP.
Устройство High Velocity Nasal Insufflation
Participants in this arm will receive high-velocity nasal insufflation therapy, a type of high-flow nasal cannula (HFNC) therapy that delivers heated and humidified oxygen at high flow rates to support patients with acute hypoxemic respiratory failure resulting from community-acquired pneumonia (CAP).

Первичные конечные точки

Treatment Failure Within 48 Hours [Срок оценки: 48 hours after randomization]

Критерии участия

Критерии включения

Age ≥ 18 years
Clinical and radiographic diagnosis of CAP
Respiratory failure using partial pressure of oxygen (PaO₂) and fraction of inspired oxygen (FiO₂) is defined by a partial pressure of oxygen/fraction of inspired oxygen ratio (PaO₂/FiO₂) ≤ 300 mmHg or a respiratory rate (RR) ≥ 25/min
Informed consent obtained