BURN-ASV Trial: Adaptive Support Ventilation in Severe Burn Injury (NCT07674563) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
BURN-ASV Trial: Adaptive Support Ventilation in Severe Burn Injury
100 participantsStarted 2026-09-23
Plain-language summary
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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ventilator-Free Days at Day 28
Timeframe: 28 days
Trial details
NCT IDNCT07674563
SponsorUkrainian Society of Regional Anesthesia and Pain Therapy