BURN-ASV Trial: Adaptive Support Ventilation in Severe Burn Injury

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUkrainian Society of Regional Anesthesia and Pain Therapy

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Adaptive Support Ventilation (ASV)

    Device

    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.

  • Conventional Lung-Protective Mechanical Ventilation

    Device

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Adaptive Support Ventilation (ASV)Experimental treatment 1 intervention
Group B: Conventional Lung-Protective Mechanical VentilationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
28 days

Secondary outcomes

1

Duration of Mechanical Ventilation

Total duration of invasive mechanical ventilation from randomization until successful liberation from ventilatory support.

Time frame
Up to 28 days
2

Oxygenation Status

Partial pressure of arterial oxygen to inspired oxygen fraction ratio (PaO₂/FiO₂).

Time frame
Days 1, 3, 7, and 14 after randomization
3

ICU Length of Stay

Number of days from ICU admission until ICU discharge.

Time frame
From randomization until hospital discharge, up to 90 days
4

Sedative Medication Exposure

Cumulative doses of propofol, midazolam, ketamine, and dexmedetomidine administered during ICU stay.

Time frame
First 28 days after randomization

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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