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.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Dmytro Dmytriiev, PhD.Professor
- Telefonszám: +380674309449
- E-mail: dmytrodmytriiev@gmail.com
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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.
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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.
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Aktív összehasonlító: 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.
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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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Ventilator-Free Days at Day 28
Időkeret: 28 days
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Ventilator-free days are defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization.
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28 days
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Duration of Mechanical Ventilation
Időkeret: Up to 28 days
|
Total duration of invasive mechanical ventilation from randomization until successful liberation from ventilatory support.
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Up to 28 days
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Oxygenation Status
Időkeret: Days 1, 3, 7, and 14 after randomization
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Partial pressure of arterial oxygen to inspired oxygen fraction ratio (PaO₂/FiO₂).
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Days 1, 3, 7, and 14 after randomization
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ICU Length of Stay
Időkeret: From randomization until hospital discharge, up to 90 days
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Number of days from ICU admission until ICU discharge.
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From randomization until hospital discharge, up to 90 days
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Sedative Medication Exposure
Időkeret: First 28 days after randomization
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Cumulative doses of propofol, midazolam, ketamine, and dexmedetomidine administered during ICU stay.
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First 28 days after randomization
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28-Day Mortality
Időkeret: 28 days
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All-cause mortality occurring within 28 days after randomization.
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28 days
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90-Day Mortality
Időkeret: 90 days
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All-cause mortality occurring within 90 days after randomization.
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90 days
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Együttműködők és nyomozók
Publikációk és hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 11v11182026
- USRA (Egyéb azonosító: Ukranian Society of Regional Anesthesia and Pain Therapy)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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 megosztási időkeret
IPD-megosztási hozzáférési feltételek
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.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
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