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

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Ventilator-Free Days at Day 28 [Time frame: 28 days]

Secondary outcome measures (6)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 21406514

Identifiers

NCT: NCT07674563 · 11v11182026 · USRA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗