Adaptive Support Ventilation Versus Conventional Lung-Protective Ventilation in Severe Burn Injury Including Thermobaric and Drone-Related Burns: The BURN-ASV Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Ventilator-Free Days at Day 28
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Adaptive Support Ventilation (ASV) (Device)
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.
干预措施: Conventional Lung-Protective Mechanical Ventilation (Device)
结局指标
主要结局
Ventilator-Free Days at Day 28
时间窗: 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.
次要结局
- 28-Day Mortality(28 days)
- 90-Day Mortality(90 days)
- Duration of Mechanical Ventilation(Up to 28 days)
- Oxygenation Status(Days 1, 3, 7, and 14 after randomization)
- ICU Length of Stay(From randomization until hospital discharge, up to 90 days)
- Sedative Medication Exposure(First 28 days after randomization)
研究者
Dmytro Dmytriiev
professor
Ukrainian Society of Regional Anesthesia and Pain Therapy