BurnBURN-ASVNCT07674563
BURN-ASV Trial: Adaptive Support Ventilation in Severe Burn Injury
A study testing Adaptive Support Ventilation (ASV) and Conventional Lung-Protective Mechanical Ventilation in people with Burn and Mechanical Ventilation, run by Ukrainian Society of Regional Anesthesia and Pain Therapy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Burn, Mechanical Ventilation, Mechanical Ventilation Complication
- What is being tested?
- Adaptive Support Ventilation (ASV) and Conventional Lung-Protective Mechanical Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2026to 23 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Burn, Mechanical Ventilation, Mechanical Ventilation Complication, ICU, ICU Hospitalization, Critical Care, Intensive Care
- Being tested
- Adaptive Support Ventilation (ASV), Conventional Lung-Protective Mechanical Ventilation
- Keywords
- burn, Combat-Related Burn Injury, adaptive support mechanical ventilation, mechanical ventilation
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 VentilationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Support Ventilation (ASV) | Experimental | Participants randomized to this arm will receive invasive mechanical ventilation using Adaptive Support Ventilation (ASV). ASV is a closed-loop ventilation mode 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. Ventilator settings may be adjusted according to predefined study protocols, blood gas analysis, and clinical judgment. Receives: Device: Adaptive Support Ventilation (ASV) |
| Conventional Lung-Protective Mechanical Ventilation | Active comparator | Participants randomized to this arm will receive conventional lung-protective mechanical ventilation using pressure-controlled or volume-controlled ventilation according to institutional standard of care. Ventilator management will follow current lung-protective ventilation principles, including low tidal volume ventilation, limitation of plateau pressure, and optimization of positive end-expiratory pressure (PEEP) based on clinical assessment and institutional protocols. Receives: Device: Conventional Lung-Protective Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (6)
Duration of Mechanical Ventilation
Total duration of invasive mechanical ventilation from randomization until successful liberation from ventilatory support.
Measured: Up to 28 days
Oxygenation Status
Partial pressure of arterial oxygen to inspired oxygen fraction ratio (PaO₂/FiO₂).
Measured: Days 1, 3, 7, and 14 after randomization
ICU Length of Stay
Number of days from ICU admission until ICU discharge.
Measured: From randomization until hospital discharge, up to 90 days
Sedative Medication Exposure
Cumulative doses of propofol, midazolam, ketamine, and dexmedetomidine administered during ICU stay.
Measured: First 28 days after randomization
28-Day Mortality
All-cause mortality occurring within 28 days after randomization.
Measured: 28 days
90-Day Mortality
All-cause mortality occurring within 90 days after randomization.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start23 Sep 2026 (estimated)
- Primary completion23 Sep 2026 (estimated)
- Study completion23 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either Adaptive Support Ventilation (ASV) or conventional lung-protective mechanical ventilation. Randomization will be performed using a computer-generated allocation sequence with stratification according to burn severity, presence of inhalation injury, thermobaric injury, and acute respiratory distress syndrome (ARDS) at enrollment. Participants will remain in their assigned treatment group throughout the study, and outcomes will be compared between groups using an intention-to-treat approach.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674563
- Sponsor's protocol ID
- 11v11182026
- Other IDs
- USRA
- Acronym
- BURN-ASV
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publications arising from this study, after de-identification, will be made available to qualified researchers upon reasonable request. Data will be available beginning 6 months and ending 5 years following publication of the primary study results. Researchers requesting access must provide a methodologically sound research proposal and sign an appropriate data access agreement. Requests will be reviewed by the study steering committee. Available data may include demographic characteristics, injury characteristics, ventilation parameters, clinical outcomes, and statistical analysis datasets necessary to reproduce the published findings. Data requests should be directed to the corresponding investigator.
Publications
Kirakli C, Ozdemir I, Ucar ZZ, Cimen P, Kepil S, Ozkan SA. Adaptive support ventilation for faster weaning in COPD: a randomised controlled trial. Eur Respir J. 2011 Oct;38(4):774-80. doi: 10.1183/09031936.00081510. Epub 2011 Mar 15.
PubMed 21406514
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07674563
- Acronym / sponsor ID
- BURN-ASV / 11v11182026
- Conditions
- Burn, Mechanical Ventilation, Mechanical Ventilation Complication, ICU, ICU Hospitalization, Critical Care, Intensive Care
- Keywords
- burn, Combat-Related Burn Injury, adaptive support mechanical ventilation, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain TherapyUniversity, hospital or other
- Study start
- 23 Sep 2026 (estimated)
- Primary completion
- 23 Sep 2026 (estimated)
- Study completion
- 23 Nov 2026 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either Adaptive Support Ventilation (ASV) or conventional lung-protective mechanical ventilation. Randomization will be performed using a computer-generated allocation sequence with stratification according to burn severity, presence of inhalation injury, thermobaric injury, and acute respiratory distress syndrome (ARDS) at enrollment. Participants will remain in their assigned treatment group throughout the study, and outcomes will be compared between groups using an intention-to-treat approach.
| Arm | Type | Receives |
|---|---|---|
| Adaptive Support Ventilation (ASV) | Experimental | Device: Adaptive Support Ventilation (ASV)Participants randomized to this arm will receive invasive mechanical ventilation using Adaptive Support Ventilation (ASV). ASV is a closed-loop ventilation mode 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. Ventilator settings may be adjusted according to predefined study protocols, blood gas analysis, and clinical judgment. |
| Conventional Lung-Protective Mechanical Ventilation | Active comparator | Device: Conventional Lung-Protective Mechanical VentilationParticipants randomized to this arm will receive conventional lung-protective mechanical ventilation using pressure-controlled or volume-controlled ventilation according to institutional standard of care. Ventilator management will follow current lung-protective ventilation principles, including low tidal volume ventilation, limitation of plateau pressure, and optimization of positive end-expiratory pressure (PEEP) based on clinical assessment and institutional protocols. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Support Ventilation (ASV)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. | Device | Adaptive Support Ventilation (ASV) |
| Conventional Lung-Protective Mechanical VentilationConventional 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. | Device | Conventional Lung-Protective Mechanical Ventilation |
Primary outcome
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.
6 secondary outcomes
Duration of Mechanical Ventilation
Time frame: Up to 28 days
Oxygenation Status
Time frame: Days 1, 3, 7, and 14 after randomization
ICU Length of Stay
Time frame: From randomization until hospital discharge, up to 90 days
Sedative Medication Exposure
Time frame: First 28 days after randomization
28-Day Mortality
Time frame: 28 days
90-Day Mortality
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Results publication: PubMed 21406514Kirakli C, Ozdemir I, Ucar ZZ, Cimen P, Kepil S, Ozkan SA. Adaptive support ventilation for faster weaning in COPD: a randomised controlled trial. Eur Respir J. 2011 Oct;38(4):774-80. doi: 10.1183/09031936.00081510. Epub 2011 Mar 15.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications arising from this study, after de-identification, will be made available to qualified researchers upon reasonable request. Data will be available beginning 6 months and ending 5 years following publication of the primary study results. Researchers requesting access must provide a methodologically sound research proposal and sign an appropriate data access agreement. Requests will be reviewed by the study steering committee. Available data may include demographic characteristics, injury characteristics, ventilation parameters, clinical outcomes, and statistical analysis datasets necessary to reproduce the published findings. Data requests should be directed to the corresponding investigator.
Related trials for Burn
Recruiting
Efferon LPS Hemoadsorption in in Patients With Thermal Burns
Burns
Not yet recruitingObservational study
Recurrence of Extremity Joint Contracture After Z-Plasty Versus Full-Thickness Skin Graft
Joint Contracture, Contracture
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruiting
Impact of Range of Motion Exercises on Pain and Functional Ability
Impact of ROM Exercises on Pain and Functional Ability in Patients With Second -Degree Burns
Enrolling by invitationObservational study
Evaluating the Accuracy of Multiple Blood Tests to Diagnose Sepsis in Adult Burn Patients
Sepsis - to Reduce Mortality in the Intensive Care Unit, Burns Involving 20% or More of Body Surface
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Support Ventilation (ASV) and Conventional Lung-Protective Mechanical Ventilation in people with Burn and Mechanical Ventilation, run by Ukrainian Society of Regional Anesthesia and Pain Therapy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmytro Dmytriiev, PhD.Professor (+380674309449, dmytrodmytriiev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-Free Days at Day 28 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07674563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.