An interventional study of Adaptive Support Ventilation (ASV) and Conventional Lung-Protective Mechanical Ventilation in Burn, Mechanical Ventilation and Mechanical Ventilation Complication, sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy. Not yet recruiting. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy · Not applicable, Interventional, and Treatment
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.
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.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →Ukrainian Society of Regional Anesthesia and Pain Therapy is the lead sponsor of 15 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Adaptive Support Ventilation (ASV)
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.
Device: Conventional Lung-Protective Mechanical Ventilation
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 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.
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
Duration of Mechanical Ventilation
Total duration of invasive mechanical ventilation from randomization until successful liberation from ventilatory support.
Time frame: Up to 28 days
Oxygenation Status
Partial pressure of arterial oxygen to inspired oxygen fraction ratio (PaO₂/FiO₂).
Time frame: Days 1, 3, 7, and 14 after randomization
ICU Length of Stay
Number of days from ICU admission until ICU discharge.
Time frame: From randomization until hospital discharge, up to 90 days
Sedative Medication Exposure
Cumulative doses of propofol, midazolam, ketamine, and dexmedetomidine administered during ICU stay.
Time frame: First 28 days after randomization
28-Day Mortality
All-cause mortality occurring within 28 days after randomization.
Time frame: 28 days
90-Day Mortality
All-cause mortality occurring within 90 days after randomization.
Time frame: 90 days
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol
Time frame: Beginning 6 months after publication of the primary study results and ending 5 years after publication.
Access criteria: De-identified individual participant data (IPD) and supporting study documentation will be available to qualified researchers, clinicians, and academic investigators whose proposed use of the data has been approved by the study steering committee. Available materials may include the study protocol, statistical analysis plan, data dictionary, and de-identified participant-level dataset necessary to reproduce published findings. Researchers requesting access must submit a methodologically sound research proposal, provide evidence of institutional affiliation, and sign a data use agreement that ensures compliance with applicable ethical, legal, and data protection requirements. Data will be provided through a secure electronic data-sharing platform or encrypted institutional data transfer following approval of the request.
Data sharing details ↗ · uaratb.org
Start is estimated for Sep 2026; primary completion for Sep 2026, 0 months later.
Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 0 months is below that.
Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Ukrainian Society of Regional Anesthesia and Pain Therapy