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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Burn; Mechanical Ventilation; War-Related Injuries; Infusion Fluid

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Dmytro Dmytriiev, PhD.Professor; Phone Number: +380674309449; Email: dmytrodmytriiev@gmail.com

Study Locations

• Ukraine
  • Vinnytsia, Ukraine, 21000
    • Vinnitsya Regional Clinical Hospital n.a Pirogov
    • Contact: Dmytro Dmytriiev, Phd; Phone Number: 0674309449; Email: dmytrodmytriiev@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static Lung Compliance	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	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	Cumulative fluid balance will be calculated as total fluid intake minus total fluid output.	Through day 7 after ICU admission
Total Fluid Volume Administered	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	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	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	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	Duration of invasive mechanical ventilation during the early observation period will be recorded.	Through day 7 after ICU admission

Collaborators and Investigators

• Sponsor: Ukrainian Society of Regional Anesthesia and Pain Therapy

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 23, 2026
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): September 23, 2026

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: July 4, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: burns; fluid therapy; war - ralated injury; addaptive support ventilation
• Additional Relevant MeSH Terms: Wounds and Injuries; War-Related Injuries; Burns
• Other Study ID Numbers: 11v213022026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No