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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Burn; Mechanical Ventilation Complication; Mechanical Ventilation; ICU; Military Activity; Critical Care, Intensive Care; ICU Hospitalization; Combat-Related Burn Injury
• Intervention / Treatment: Device: Adaptive Support Ventilation (ASV); Device: Conventional Lung-Protective Mechanical Ventilation

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dmytro Dmytriiev, PhD.Professor; Phone Number: +380674309449; Email: dmytrodmytriiev@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: Conventional Lung-Protective Mechanical Ventilation; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Mechanical Ventilation	Total duration of invasive mechanical ventilation from randomization until successful liberation from ventilatory support.	Up to 28 days
Oxygenation Status	Partial pressure of arterial oxygen to inspired oxygen fraction ratio (PaO₂/FiO₂).	Days 1, 3, 7, and 14 after randomization
ICU Length of Stay	Number of days from ICU admission until ICU discharge.	From randomization until hospital discharge, up to 90 days
Sedative Medication Exposure	Cumulative doses of propofol, midazolam, ketamine, and dexmedetomidine administered during ICU stay.	First 28 days after randomization
28-Day Mortality	All-cause mortality occurring within 28 days after randomization.	28 days
90-Day Mortality	All-cause mortality occurring within 90 days after randomization.	90 days

Collaborators and Investigators

• Sponsor: Ukrainian Society of Regional Anesthesia and Pain Therapy

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 23, 2026
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): November 23, 2026

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: mechanical ventilation; burn; Combat-Related Burn Injury; adaptive support mechanical ventilation
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 11v11182026; USRA (Other Identifier: Ukranian Society of Regional Anesthesia and Pain Therapy)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Beginning 6 months after publication of the primary study results and ending 5 years after publication.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No