Vinnitsya Regional Clinical Hospital n.a Pirogov
Vinnytsia, 21000, Ukraine
NCT Number: NCT07689097
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.
Trial opening soon.
Get Notified18 year–50 year
All sexes
Observational
Vinnytsia, 21000, Ukraine
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Oxygenation will be assessed using the PaO₂/FiO₂ ratio in adult patients with severe burn injury receiving Adaptive Support Ventilation and targeted fluid resuscitation.
Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Static lung compliance will be assessed using ventilator-derived respiratory mechanics.
Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Driving pressure will be calculated as plateau pressure minus positive end-expiratory pressure.
Time frame: Through day 7 after ICU admission
Cumulative fluid balance will be calculated as total fluid intake minus total fluid output.
Time frame: First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
Total fluid volume administered will be recorded and expressed as mL/kg/% total body surface area burned.
Time frame: First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
Urine output will be recorded as mL/kg/hour.
Time frame: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Lactate clearance will be calculated from serial serum lactate measurements.
Time frame: Through day 7 after ICU admission
Need for vasopressor support and duration of vasopressor therapy will be recorded.
Time frame: Through day 7 after ICU admission
Duration of invasive mechanical ventilation during the early observation period will be recorded.
Contact information is provided by the study sponsor or research team.
Ukrainian Society of Regional Anesthesia and Pain Therapy
Other
Adaptive Support Ventilation and Targeted Fluid Resuscitation in Patients With Severe Burn Injury: A Prospective Cohort Study
Acronym: BURN-ASV/TFR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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