BURN-ASV Trial: Adaptive Support Ventilation in Severe Burn Injury (BURN-ASV)
Adaptive Support Ventilation Versus Conventional Lung-Protective Ventilation in Severe Burn Injury Including Thermobaric and Drone-Related Burns: The BURN-ASV Randomized Controlled Trial
Severe burn injury frequently requires prolonged mechanical ventilation because of inhalation injury, respiratory failure, systemic inflammation, and repeated surgical procedures. Patients with extensive burns are at high risk of ventilator-associated complications, prolonged intensive care unit (ICU) stay, and death.
Adaptive Support Ventilation (ASV) is an automated mode of mechanical ventilation that continuously adjusts breathing support according to the patient's respiratory needs and lung mechanics. Although ASV has shown potential benefits in general ICU populations, its effectiveness in patients with severe burn injuries has not been adequately studied.
The purpose of this randomized controlled trial is to compare Adaptive Support Ventilation with conventional lung-protective mechanical ventilation in critically ill adult burn patients, including those with inhalation injury, drone-related burns, and thermobaric blast burns. Participants will be randomly assigned to receive either ASV or conventional ventilation. The study will evaluate whether ASV improves ventilator-free days, reduces duration of mechanical ventilation, decreases ventilator-associated complications, and improves clinical outcomes.
The results of this study may help identify optimal ventilation strategies for patients with severe burn injuries and improve critical care management in both civilian and military burn centers.
Обзор исследования
Статус
Условия
Подробное описание
Severe burn injury is frequently complicated by respiratory failure resulting from inhalation injury, systemic inflammation, pulmonary edema, acute respiratory distress syndrome (ARDS), and prolonged critical illness. Mechanical ventilation is often required for extended periods and is associated with substantial morbidity, including ventilator-associated pneumonia, ventilator-induced lung injury, prolonged sedation exposure, and increased intensive care unit (ICU) length of stay.
Modern military conflicts have introduced new mechanisms of burn injury, including drone-delivered munitions and thermobaric explosive devices. These injuries are often characterized by a combination of thermal injury, blast overpressure, airway damage, inhalation injury, and severe pulmonary dysfunction. As a result, optimization of ventilatory support has become an important component of burn critical care.
Adaptive Support Ventilation (ASV) is a closed-loop mode of mechanical ventilation that automatically adjusts respiratory rate, tidal volume, inspiratory pressure, and minute ventilation according to patient respiratory mechanics and predicted physiologic requirements. Previous studies in mixed ICU populations have suggested that ASV may improve patient-ventilator synchrony, reduce work of breathing, facilitate weaning, and decrease the duration of mechanical ventilation. However, evidence regarding its use in severe burn patients remains limited.
The BURN-ASV Trial is a prospective randomized controlled study designed to compare Adaptive Support Ventilation with conventional lung-protective mechanical ventilation in critically ill adult burn patients requiring invasive mechanical ventilation. Participants will be randomized in a 1:1 ratio to receive either ASV or conventional ventilation according to institutional standards of care. Randomization will be stratified by burn severity, inhalation injury, thermobaric injury, and the presence of ARDS.
The primary objective is to determine whether ASV increases ventilator-free days during the first 28 days following randomization. Secondary objectives include evaluation of mechanical ventilation duration, ventilator-associated complications, oxygenation, ventilator mechanics, sedation and opioid requirements, ICU and hospital length of stay, and mortality.
The results of this study are expected to provide evidence regarding the effectiveness and safety of automated ventilation strategies in patients with severe burn injuries and may contribute to future recommendations for respiratory support in both civilian and military burn intensive care settings.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Dmytro Dmytriiev, PhD.Professor
- Номер телефона: +380674309449
- Электронная почта: dmytrodmytriiev@gmail.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age 18 years or older.
- Thermal burn injury involving ≥20% total body surface area (TBSA).
- Requirement for invasive mechanical ventilation expected to exceed 24 hours.
- Admission to a participating intensive care unit within 48 hours of injury.
- Burn injury resulting from conventional flame burns, explosion-related burns, drone-related burns, or thermobaric blast burns.
- Written informed consent provided by the patient or a legally authorized representative.
Exclusion Criteria:
- Age younger than 18 years.
- Pregnancy or breastfeeding.
- Pre-existing chronic respiratory failure requiring home oxygen therapy or long-term mechanical ventilation.
- Severe chronic obstructive pulmonary disease (COPD GOLD IV) or other end-stage pulmonary disease.
- Extracorporeal membrane oxygenation (ECMO) at the time of enrollment.
- Severe traumatic brain injury requiring controlled hyperventilation.
- Expected death within 24 hours of ICU admission.
- Do-not-resuscitate (DNR) order or limitations of life-sustaining treatment.
- Previous enrollment in the current study.
- Participation in another interventional trial that may interfere with study outcomes.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Adaptive Support Ventilation (ASV)
Participants randomized to this arm will receive invasive mechanical ventilation using Adaptive Support Ventilation (ASV).
ASV is a closed-loop ventilation mode that automatically adjusts respiratory rate, tidal volume, inspiratory pressure, and minute ventilation according to patient respiratory mechanics and predicted physiologic requirements while maintaining lung-protective ventilation principles.
Ventilator settings may be adjusted according to predefined study protocols, blood gas analysis, and clinical judgment.
|
Adaptive Support Ventilation (ASV) is a closed-loop mode of invasive mechanical ventilation that automatically adjusts respiratory rate, tidal volume, inspiratory pressure, and minute ventilation according to patient respiratory mechanics and predicted physiologic requirements while maintaining lung-protective ventilation principles.
|
|
Активный компаратор: Conventional Lung-Protective Mechanical Ventilation
Participants randomized to this arm will receive conventional lung-protective mechanical ventilation using pressure-controlled or volume-controlled ventilation according to institutional standard of care.
Ventilator management will follow current lung-protective ventilation principles, including low tidal volume ventilation, limitation of plateau pressure, and optimization of positive end-expiratory pressure (PEEP) based on clinical assessment and institutional protocols.
|
Conventional invasive mechanical ventilation delivered using pressure-controlled or volume-controlled modes according to institutional standards of care and lung-protective ventilation principles, including low tidal volume ventilation and limitation of airway pressures.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Ventilator-Free Days at Day 28
Временное ограничение: 28 days
|
Ventilator-free days are defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization.
|
28 days
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Duration of Mechanical Ventilation
Временное ограничение: Up to 28 days
|
Total duration of invasive mechanical ventilation from randomization until successful liberation from ventilatory support.
|
Up to 28 days
|
|
Oxygenation Status
Временное ограничение: Days 1, 3, 7, and 14 after randomization
|
Partial pressure of arterial oxygen to inspired oxygen fraction ratio (PaO₂/FiO₂).
|
Days 1, 3, 7, and 14 after randomization
|
|
ICU Length of Stay
Временное ограничение: From randomization until hospital discharge, up to 90 days
|
Number of days from ICU admission until ICU discharge.
|
From randomization until hospital discharge, up to 90 days
|
|
Sedative Medication Exposure
Временное ограничение: First 28 days after randomization
|
Cumulative doses of propofol, midazolam, ketamine, and dexmedetomidine administered during ICU stay.
|
First 28 days after randomization
|
|
28-Day Mortality
Временное ограничение: 28 days
|
All-cause mortality occurring within 28 days after randomization.
|
28 days
|
|
90-Day Mortality
Временное ограничение: 90 days
|
All-cause mortality occurring within 90 days after randomization.
|
90 days
|
Соавторы и исследователи
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 11v11182026
- USRA (Другой идентификатор: Ukranian Society of Regional Anesthesia and Pain Therapy)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Individual participant data that underlie the results reported in publications arising from this study, after de-identification, will be made available to qualified researchers upon reasonable request.
Data will be available beginning 6 months and ending 5 years following publication of the primary study results.
Researchers requesting access must provide a methodologically sound research proposal and sign an appropriate data access agreement. Requests will be reviewed by the study steering committee.
Available data may include demographic characteristics, injury characteristics, ventilation parameters, clinical outcomes, and statistical analysis datasets necessary to reproduce the published findings.
Data requests should be directed to the corresponding investigator.
Сроки обмена IPD
Критерии совместного доступа к IPD
De-identified individual participant data (IPD) and supporting study documentation will be available to qualified researchers, clinicians, and academic investigators whose proposed use of the data has been approved by the study steering committee.
Available materials may include the study protocol, statistical analysis plan, data dictionary, and de-identified participant-level dataset necessary to reproduce published findings.
Researchers requesting access must submit a methodologically sound research proposal, provide evidence of institutional affiliation, and sign a data use agreement that ensures compliance with applicable ethical, legal, and data protection requirements.
Data will be provided through a secure electronic data-sharing platform or encrypted institutional data transfer following approval of the request.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .