ASV and Targeted Fluid Resuscitation in Severe Burns
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorUkrainian Society of Regional Anesthesia and Pain Therapy
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age younger than 18 years.
Burn injury involving <20% TBSA.
Mechanical ventilation initiated more than 24 hours after ICU admission.
Pregnancy.
Trial population
The study population will consist of adult patients admitted to the intensive care unit with severe burn injury requiring invasive mechanical ventilation during the acute phase of treatment. Patients will receive Adaptive Support Ventilation (ASV) and targeted fluid resuscitation as part of routine clinical care. The study will include patients with thermal, flame, scald, electrical, chemical, and combat-related burn injuries, including burns associated with drone and thermobaric attacks, when applicable. Clinical, respiratory, hemodynamic, and laboratory data will be collected prospectively during the first seven days of intensive care to evaluate respiratory function, fluid resuscitation, and early clinical outcomes.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Adaptive Support Ventilation With Targeted Fluid Resuscitation
Trial outcomes
Primary outcomes
1
Change in Oxygenation Index During the First 7 Days
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 admissionSecondary outcomes
1
Static Lung Compliance
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 admission2
Driving Pressure
Driving pressure will be calculated as plateau pressure minus positive end-expiratory pressure.
Time frame
Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission3
Cumulative Fluid Balance
Cumulative fluid balance will be calculated as total fluid intake minus total fluid output.
Time frame
Through day 7 after ICU admission4
Total Fluid Volume Administered
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 admissionSponsors and contacts
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Source ClinicalTrials.gov
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