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ASV and Targeted Fluid Resuscitation in Severe Burns (BURN-ASV/TFR)

4. července 2026 aktualizováno: Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy

Adaptive Support Ventilation and Targeted Fluid Resuscitation in Patients With Severe Burn Injury: A Prospective Cohort Study

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

100

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Ukrajina
      • Vinnytsia, Ukrajina, 21000
        • Vinnitsya Regional Clinical Hospital n.a Pirogov
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Adaptive Support Ventilation With Targeted Fluid Resuscitation
Adult patients with severe burn injury requiring invasive mechanical ventilation who are managed using Adaptive Support Ventilation (ASV) together with targeted fluid resuscitation during the early phase of intensive care. All treatments are delivered as part of routine clinical practice, and clinical, respiratory, hemodynamic, and laboratory data are collected prospectively.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Oxygenation Index During the First 7 Days
Časové okno: 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.
Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Static Lung Compliance
Časové okno: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Static lung compliance will be assessed using ventilator-derived respiratory mechanics.
Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Driving Pressure
Časové okno: 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.
Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Cumulative Fluid Balance
Časové okno: Through day 7 after ICU admission
Cumulative fluid balance will be calculated as total fluid intake minus total fluid output.
Through day 7 after ICU admission
Total Fluid Volume Administered
Časové okno: 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.
First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
Urine Output
Časové okno: First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
Urine output will be recorded as mL/kg/hour.
First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
Lactate Clearance
Časové okno: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Lactate clearance will be calculated from serial serum lactate measurements.
Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
Vasopressor Requirement
Časové okno: Through day 7 after ICU admission
Need for vasopressor support and duration of vasopressor therapy will be recorded.
Through day 7 after ICU admission
Mechanical Ventilation Duration During Early ICU Period
Časové okno: Through day 7 after ICU admission
Duration of invasive mechanical ventilation during the early observation period will be recorded.
Through day 7 after ICU admission

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

23. září 2026

Primární dokončení (Odhadovaný)

23. září 2026

Dokončení studie (Odhadovaný)

23. září 2026

Termíny zápisu do studia

První předloženo

29. června 2026

První předloženo, které splnilo kritéria kontroly kvality

4. července 2026

První zveřejněno (Aktuální)

8. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. července 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 11v213022026

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

De-identified individual participant data (IPD) underlying the results reported in this study will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the primary study results and following approval of a methodologically sound research proposal. Shared data will include demographic characteristics, burn severity, respiratory parameters, fluid resuscitation variables, laboratory measurements, and outcome data. Data sharing will require a signed data access agreement to ensure participant confidentiality and compliance with institutional and ethical requirements.

Časový rámec sdílení IPD

Individual participant data (IPD) will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following publication.

Kritéria přístupu pro sdílení IPD

Access to de-identified individual participant data (IPD), the study protocol, and the statistical analysis plan will be provided to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the principal investigator. Approved researchers will be required to sign a data use agreement before access is granted. Data will be shared in a secure electronic format while maintaining participant confidentiality and compliance with institutional and ethical requirements.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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