About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Adaptive Support Ventilation (ASV)
DeviceAdaptive 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.
Conventional Lung-Protective Mechanical Ventilation
DeviceConventional 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.
Treatment groups
Trial outcomes
Primary outcomes
Ventilator-Free Days at Day 28
Ventilator-free days are defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization.
Secondary outcomes
Duration of Mechanical Ventilation
Total duration of invasive mechanical ventilation from randomization until successful liberation from ventilatory support.
Oxygenation Status
Partial pressure of arterial oxygen to inspired oxygen fraction ratio (PaO₂/FiO₂).
ICU Length of Stay
Number of days from ICU admission until ICU discharge.
Sedative Medication Exposure
Cumulative doses of propofol, midazolam, ketamine, and dexmedetomidine administered during ICU stay.
Locations
Sponsors and contacts
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