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Not Yet Recruiting NCT07674563

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

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

Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Ukrainian Society of Regional Anesthesia and Pain Therapy

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07674563). StuddyBuddy aggregates publicly available trial information.