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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Dmytro Dmytriiev, PhD.Professor
- 전화번호: +380674309449
- 이메일: dmytrodmytriiev@gmail.com
연구 장소
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Vinnytsia, 우크라이나, 21000
- Vinnitsya Regional Clinical Hospital n.a Pirogov
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연락하다:
- Dmytro Dmytriiev, Phd
- 전화번호: 0674309449
- 이메일: dmytrodmytriiev@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Oxygenation Index During the First 7 Days
기간: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
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Oxygenation will be assessed using the PaO₂/FiO₂ ratio in adult patients with severe burn injury receiving Adaptive Support Ventilation and targeted fluid resuscitation.
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Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Static Lung Compliance
기간: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
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Static lung compliance will be assessed using ventilator-derived respiratory mechanics.
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Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
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Driving Pressure
기간: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
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Driving pressure will be calculated as plateau pressure minus positive end-expiratory pressure.
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Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
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Cumulative Fluid Balance
기간: Through day 7 after ICU admission
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Cumulative fluid balance will be calculated as total fluid intake minus total fluid output.
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Through day 7 after ICU admission
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Total Fluid Volume Administered
기간: First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
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Total fluid volume administered will be recorded and expressed as mL/kg/% total body surface area burned.
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First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
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Urine Output
기간: First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
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Urine output will be recorded as mL/kg/hour.
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First 24 hours, 48 hours, 72 hours, and through day 7 after ICU admission
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Lactate Clearance
기간: Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
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Lactate clearance will be calculated from serial serum lactate measurements.
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Baseline, 24 hours, 48 hours, 72 hours, and day 7 after ICU admission
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Vasopressor Requirement
기간: Through day 7 after ICU admission
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Need for vasopressor support and duration of vasopressor therapy will be recorded.
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Through day 7 after ICU admission
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Mechanical Ventilation Duration During Early ICU Period
기간: Through day 7 after ICU admission
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Duration of invasive mechanical ventilation during the early observation period will be recorded.
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Through day 7 after ICU admission
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 11v213022026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
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