ASV and Targeted Fluid Resuscitation in Severe Burns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Burn, War-Related Injuries, Mechanical Ventilation, Infusion Fluid. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ukraine
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Adaptive Support Ventilation and Targeted Fluid Resuscitation in Patients With Severe Burn Injury: A Prospective Cohort Study
Overview
This prospective cohort study will evaluate the use of Adaptive Support Ventilation (ASV) together with targeted fluid resuscitation in adult patients with severe burn injuries requiring mechanical ventilation in the intensive care unit. Patients with extensive burns often develop respiratory failure and require both invasive mechanical ventilation and large-volume fluid resuscitation during the first days after injury. The study will assess whether the combination of ASV and targeted fluid resuscitation is associated with improved oxygenation, respiratory mechanics, fluid balance, and early clinical outcomes during the first 72 hours of intensive care. Clinical data, ventilatory parameters, laboratory results, hemodynamic variables, and fluid resuscitation characteristics will be collected as part of routine clinical care. The findings may help optimize early intensive care management for patients with severe burn injuries and improve future treatment strategies.
Detailed description
Severe burn injury is frequently associated with profound systemic inflammation, capillary leak syndrome, hypovolemic shock, inhalation injury, and acute respiratory failure requiring invasive mechanical ventilation. The first 72 hours following injury represent a critical phase during which both ventilatory support and fluid resuscitation substantially influence organ function and subsequent clinical outcomes.
Adaptive Support Ventilation (ASV) is a closed-loop mechanical ventilation mode that automatically adjusts ventilatory parameters according to the patient's respiratory mechanics while maintaining predefined ventilation targets. This approach has the potential to optimize lung-protective ventilation, reduce unnecessary ventilatory stress, and improve patient-ventilator synchrony. At the same time, targeted fluid resuscitation aims to individualize fluid administration based on physiological and clinical parameters in order to maintain adequate tissue perfusion while minimizing fluid overload and the development of burn-related edema.
This prospective cohort study will evaluate the association between the combined use of Adaptive Support Ventilation and targeted fluid resuscitation during the early management of adult patients with severe burn injuries admitted to the intensive care unit. Patients will be managed according to institutional protocols, and no study-specific interventions will be introduced beyond routine clinical practice.
Clinical, respiratory, hemodynamic, and laboratory data will be collected prospectively during the first 72 hours after intensive care unit admission. Ventilatory variables, oxygenation indices, respiratory mechanics, fluid administration, cumulative fluid balance, urine output, and organ dysfunction parameters will be recorded using standard monitoring systems and electronic medical records.
The study aims to characterize the physiological effects of early Adaptive Support Ventilation combined with targeted fluid resuscitation and to evaluate their association with respiratory function, fluid balance, and early clinical outcomes in patients with severe burn injury. The findings are expected to provide real-world evidence to support optimization of intensive care strategies for critically ill burn patients.
Primary outcome measures
- Change in Oxygenation Index During the First 7 Days [Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission]
Secondary outcome measures (8)
- Static Lung Compliance [Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission]
- Driving Pressure [Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission]
- Cumulative Fluid Balance [Time frame: Through day 7 after ICU admission]
- Total Fluid Volume Administered [Time frame: First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission]
- Urine Output [Time frame: First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission]
- Lactate Clearance [Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission]
- Vasopressor Requirement [Time frame: Through day 7 after ICU admission]
- Mechanical Ventilation Duration During Early ICU Period [Time frame: Through day 7 after ICU admission]
Eligibility criteria
Inclusion criteria
- Adults aged 18 years or older.
- Hospital admission with severe burn injury involving ≥20% total body surface area (TBSA).
- Requirement for invasive mechanical ventilation within 24 hours after admission to the intensive care unit.
- Expected need for mechanical ventilation for at least 48 hours.
- Treatment with Adaptive Support Ventilation (ASV) and targeted fluid resuscitation according to institutional protocols.
- Written informed consent provided by the patient or legally authorized representative, in accordance with local regulations.
Exclusion criteria
- Age younger than 18 years.
- Burn injury involving <20% TBSA.
- Mechanical ventilation initiated more than 24 hours after ICU admission.
- Pregnancy.
- Pre-existing chronic dependence on invasive mechanical ventilation.
- Severe traumatic brain injury requiring a specific ventilation strategy.
- Terminal illness with an expected survival of less than 24 hours.
- Enrollment in another interventional clinical trial that may influence study outcomes.
- Inability to obtain essential clinical data required for study analysis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Ukraine · 1 center
- Vinnitsya Regional Clinical Hospital n.a Pirogov — Vinnytsia
Publications
- Kakizaki R, Fukuda S, Liu K, Nakamoto K, Batsaikhan TA, Khan MN, Branson RD, Enkhbaatar P, Kinsky MP. CLOSED-LOOP VENTILATION AND OXYGENATION WITH DECISION SUPPORT FLUID RESUSCITATION TO TREAT MAJOR BURN INJURY WITH SMOKE-INDUCED ACUTE RESPIRATORY DISTRESS SYNDROME. Shock. 2025 May 1;63(5):781-787. doi: 10.1097/SHK.0000000000002552. Epub 2025 Jan 22. PMID 39840968
Identifiers
NCT: NCT07689097 · 11v213022026