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

NCT07674563 | Not Yet Recruiting DMC

• 2 other identifiers: 11v11182026USRA
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Burn; Mechanical Ventilation; Mechanical Ventilation Complication; ICU; ICU Hospitalization; Critical Care, Intensive Care; Military Activity; Combat-Related Burn Injury

Keywords

burn; Combat-Related Burn Injury; adaptive support mechanical ventilation; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of Mechanical Ventilation

  Up to 28 days

• Oxygenation Status

  Days 1, 3, 7, and 14 after randomization

• ICU Length of Stay

  From randomization until hospital discharge, up to 90 days

• Sedative Medication Exposure

  First 28 days after randomization

• 28-Day Mortality

  28 days

Study Arms (2)

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.

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.

Device: Conventional Lung-Protective Mechanical Ventilation

Interventions

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.

Adaptive Support Ventilation (ASV)

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.

Conventional Lung-Protective Mechanical Ventilation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ukrainian Society of Regional Anesthesia and Pain Therapy: lead

Related Publications (1)

• 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.

  PMID: 21406514 RESULT

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Dmytro Dmytriiev, PhD.Professor

CONTACT

+380674309449; dmytrodmytriiev@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 29, 2026
• Study Start (Estimated): September 23, 2026
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): November 23, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.