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NCT Number: NCT07674563

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Ventilator-Free Days at Day 28

    Time frame: 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.

Secondary outcomes

  1. Duration of Mechanical Ventilation

    Time frame: Up to 28 days

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

  2. Oxygenation Status

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

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

  3. ICU Length of Stay

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

    Number of days from ICU admission until ICU discharge.

  4. Sedative Medication Exposure

    Time frame: First 28 days after randomization

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

  5. 28-Day Mortality

    Time frame: 28 days

    All-cause mortality occurring within 28 days after randomization.

  6. 90-Day Mortality

    Time frame: 90 days

    All-cause mortality occurring within 90 days after randomization.

Study contacts

Contact information is provided by the study sponsor or research team.

Dmytro Dmytriiev, PhD.Professor

CONTACT

[email protected]

+380674309449

Sponsors and collaborators

Lead sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Other

Registry information

Official study title

Adaptive Support Ventilation Versus Conventional Lung-Protective Ventilation in Severe Burn Injury Including Thermobaric and Drone-Related Burns: The BURN-ASV Randomized Controlled Trial

Acronym: BURN-ASV

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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