Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

4 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Ucraina
      • Vinnytsia, Ucraina, 21000
        • Vinnitsya Regional Clinical Hospital n.a Pirogov
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Oxygenation Index During the First 7 Days
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Static Lung Compliance
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

23 settembre 2026

Completamento primario (Stimato)

23 settembre 2026

Completamento dello studio (Stimato)

23 settembre 2026

Date di iscrizione allo studio

Primo inviato

29 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 luglio 2026

Primo Inserito (Effettivo)

8 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 11v213022026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione 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.

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Bruciare

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Equatorial Guinea

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi