Adaptive Support Ventilation and Targeted Fluid Resuscitation in Patients With Severe Burn Injury: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Oxygenation Index During the First 7 Days
研究概览
简要总结
This prospective cohort study will evaluate the use of Adaptive Support Ventilation (ASV) together with targeted fluid resuscitation in adult patients with severe burn injuries requiring mechanical ventilation in the intensive care unit.
Patients with extensive burns often develop respiratory failure and require both invasive mechanical ventilation and large-volume fluid resuscitation during the first days after injury. The study will assess whether the combination of ASV and targeted fluid resuscitation is associated with improved oxygenation, respiratory mechanics, fluid balance, and early clinical outcomes during the first 72 hours of intensive care.
Clinical data, ventilatory parameters, laboratory results, hemodynamic variables, and fluid resuscitation characteristics will be collected as part of routine clinical care. The findings may help optimize early intensive care management for patients with severe burn injuries and improve future treatment strategies.
详细描述
Severe burn injury is frequently associated with profound systemic inflammation, capillary leak syndrome, hypovolemic shock, inhalation injury, and acute respiratory failure requiring invasive mechanical ventilation. The first 72 hours following injury represent a critical phase during which both ventilatory support and fluid resuscitation substantially influence organ function and subsequent clinical outcomes.
Adaptive Support Ventilation (ASV) is a closed-loop mechanical ventilation mode that automatically adjusts ventilatory parameters according to the patient's respiratory mechanics while maintaining predefined ventilation targets. This approach has the potential to optimize lung-protective ventilation, reduce unnecessary ventilatory stress, and improve patient-ventilator synchrony. At the same time, targeted fluid resuscitation aims to individualize fluid administration based on physiological and clinical parameters in order to maintain adequate tissue perfusion while minimizing fluid overload and the development of burn-related edema.
This prospective cohort study will evaluate the association between the combined use of Adaptive Support Ventilation and targeted fluid resuscitation during the early management of adult patients with severe burn injuries admitted to the intensive care unit. Patients will be managed according to institutional protocols, and no study-specific interventions will be introduced beyond routine clinical practice.
Clinical, respiratory, hemodynamic, and laboratory data will be collected prospectively during the first 72 hours after intensive care unit admission. Ventilatory variables, oxygenation indices, respiratory mechanics, fluid administration, cumulative fluid balance, urine output, and organ dysfunction parameters will be recorded using standard monitoring systems and electronic medical records.
The study aims to characterize the physiological effects of early Adaptive Support Ventilation combined with targeted fluid resuscitation and to evaluate their association with respiratory function, fluid balance, and early clinical outcomes in patients with severe burn injury. The findings are expected to provide real-world evidence to support optimization of intensive care strategies for critically ill burn patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults aged 18 years or older.
- •Hospital admission with severe burn injury involving ≥20% total body surface area (TBSA).
- •Requirement for invasive mechanical ventilation within 24 hours after admission to the intensive care unit.
- •Expected need for mechanical ventilation for at least 48 hours.
- •Treatment with Adaptive Support Ventilation (ASV) and targeted fluid resuscitation according to institutional protocols.
- •Written informed consent provided by the patient or legally authorized representative, in accordance with local regulations.
排除标准
- •Age younger than 18 years.
- •Burn injury involving <20% TBSA.
- •Mechanical ventilation initiated more than 24 hours after ICU admission.
- •Pregnancy.
- •Pre-existing chronic dependence on invasive mechanical ventilation.
- •Severe traumatic brain injury requiring a specific ventilation strategy.
- •Terminal illness with an expected survival of less than 24 hours.
- •Enrollment in another interventional clinical trial that may influence study outcomes.
- •Inability to obtain essential clinical data required for study analysis.
结局指标
主要结局
Change in Oxygenation Index During the First 7 Days
时间窗: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Oxygenation will be assessed using the PaO₂/FiO₂ ratio in adult patients with severe burn injury receiving Adaptive Support Ventilation and targeted fluid resuscitation.
次要结局
- Static Lung Compliance(Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission)
- Driving Pressure(Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission)
- Cumulative Fluid Balance(Through day 7 after ICU admission)
- Total Fluid Volume Administered(First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission)
- Urine Output(First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission)
- Lactate Clearance(Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission)
- Vasopressor Requirement(Through day 7 after ICU admission)
- Mechanical Ventilation Duration During Early ICU Period(Through day 7 after ICU admission)
研究者
Dmytro Dmytriiev
professor, head of intensive care department
Ukrainian Society of Regional Anesthesia and Pain Therapy