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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Dmytro Dmytriiev, PhD.Professor
- Número de telefone: +380674309449
- E-mail: dmytrodmytriiev@gmail.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
|
Comparador Ativo: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Ventilator-Free Days at Day 28
Prazo: 28 days
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Duration of Mechanical Ventilation
Prazo: Up to 28 days
|
Total duration of invasive mechanical ventilation from randomization until successful liberation from ventilatory support.
|
Up to 28 days
|
|
Oxygenation Status
Prazo: Days 1, 3, 7, and 14 after randomization
|
Partial pressure of arterial oxygen to inspired oxygen fraction ratio (PaO₂/FiO₂).
|
Days 1, 3, 7, and 14 after randomization
|
|
ICU Length of Stay
Prazo: From randomization until hospital discharge, up to 90 days
|
Number of days from ICU admission until ICU discharge.
|
From randomization until hospital discharge, up to 90 days
|
|
Sedative Medication Exposure
Prazo: First 28 days after randomization
|
Cumulative doses of propofol, midazolam, ketamine, and dexmedetomidine administered during ICU stay.
|
First 28 days after randomization
|
|
28-Day Mortality
Prazo: 28 days
|
All-cause mortality occurring within 28 days after randomization.
|
28 days
|
|
90-Day Mortality
Prazo: 90 days
|
All-cause mortality occurring within 90 days after randomization.
|
90 days
|
Colaboradores e Investigadores
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 11v11182026
- USRA (Outro identificador: Ukranian Society of Regional Anesthesia and Pain Therapy)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .