Local Assessment of Management of Burn Patients (LAMiNAR)
Local Assessment of Management of Burn Patients (LAMiNAR) - a Prospective Observational International Multicenter Cohort Study
In the general intensive care unit (ICU) population, there is strong evidence for benefit from lung-protective mechanical ventilation, including the use of low tidal volumes and adequate levels of positive end-expiratory pressure (PEEP). In burn patients it is highly uncertain whether these settings are beneficial and there are even concerns over safety of, in particular use of low tidal volumes. There is lack of international guidelines and consequently ventilation practice in burn patients may widely vary.
The primary objective is to determine ventilation practice in burn ICUs worldwide, focusing on the size of tidal volumes and the levels of PEEP used for burn patients. In addition, data on other strategies considered important in patients who receive ventilation are also collected, including data on neuromuscular blocking agents, sedatives and analgesics, and type and amount of intravenous fluids used in the period of ventilation. The secondary objective is to determine the association between tidal volume size and levels of PEEP, and duration of ventilation in burn patients.
연구 개요
상세 설명
Patient population: Consecutive burn patients admitted to participating burn ICUs who receive invasive ventilation, irrespective of severity of burn injury and/or presence of inhalation trauma are eligible for participation.
Data collection: includes burn patients admitted within a period of three months. Demographic and baseline data are collected from the clinical files on the day of admission. If available, standard of care and clinical outcome parameters are collected daily until day 14, death or discharge from ICU, whatever comes first.
Sample size: The primary objective is to determine (variations in) ventilation practice in burn patients in burn ICUs. Therefore, the sample size is based on the main secondary objective, which is to determine the association between the following ventilator settings: tidal volume, PEEP, FiO2 and mode; and outcome of burn patients. The investigators calculated the sample size for a multiple regression model: a sample size of at least 300 patients is required to have a power of 0.80, a significance level of 0.05, using an estimated effect size of 0.04, while using 4 independent variables in the model.
Ethics Approval: National coordinators will be responsible for clarifying the need for ethics approval and applying for this where appropriate according to local policy. Centres will not be permitted to record data unless ethics approval or an equivalent waiver is in place. The investigators expect that in most, if not every participating country, a patient informed consent is not be required.
Monitoring: Due to the observational nature of the study, a DSMB is not necessary.
Organization: National co-ordinators will lead the project within individual nations and identify participating hospitals, translate study paperwork, distribute study paperwork and ensure necessary regulatory approvals are in place. They provide assistance to the participating clinical sites in trial management, record keeping and data management. Local coordinators in each site will supervise data collection and ensure adherence to Good Clinical Practice during the trial.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Zuid Holland
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Amsterdam, Zuid Holland, 네덜란드, 1105AZ
- Academic Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Burns
- Admission to a participating burn ICU Need for invasive ventilation
- Informed consent (only if applicable in the country where data are collected)
Exclusion Criteria:
- None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Ventilation parameters
기간: Up to 14 days during mechanical ventilation
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Tidal volume size; milliliters per kilogram of predicted body weight
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Up to 14 days during mechanical ventilation
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Ventilation parameters
기간: Up to 14 days during mechanical ventilation
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Level of positive end-expiratory pressure (PEEP); cm H2O
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Up to 14 days during mechanical ventilation
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Ventilation parameters
기간: Up to 14 days during mechanical ventilation
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Fraction of oxygen in inspired air (FiO2), %
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Up to 14 days during mechanical ventilation
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Ventilation parameters
기간: Up to 14 days during mechanical ventilation
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Mode of ventilation; assist-control or spontaneous modes of ventilation
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Up to 14 days during mechanical ventilation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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90일째 ICU 체류 기간
기간: 90일까지
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입원과 퇴원 또는 사망 사이의 시간
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90일까지
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90일차 입원 기간
기간: 90일까지
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입원과 퇴원 또는 사망 사이의 시간
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90일까지
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모든 원인의 ICU 사망률
기간: 90일까지
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ICU 입원 중 모든 사망
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90일까지
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모든 원인의 병원 사망률
기간: 90일까지
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입원 중 사망
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90일까지
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Number of ventilator-free days and alive at day 28
기간: From day 1 to day 28
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Defined as the number of days, from day 1 to day 28, the patient is alive and breathes without assistance of a mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours.
Notably, if after successful withdrawal of mechanical ventilation the patient requires ventilation for a surgical procedure, this will not count as a 'ventilator day'.
If ventilation is prolonged after surgery due to respiratory insufficiency, the day(s) ventilation is required counts as a 'ventilator day'
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From day 1 to day 28
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Other Ventilation Parameters
기간: Up to 14 days during mechanical ventilation
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Peak and plateau pressures or maximum airway pressure
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Up to 14 days during mechanical ventilation
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Other Ventilation Parameters
기간: Up to 14 days during mechanical ventilation
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Respiratory rate
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Up to 14 days during mechanical ventilation
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Other Ventilation Parameters
기간: Up to 14 days during mechanical ventilation
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Inspiration to expiration ratio
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Up to 14 days during mechanical ventilation
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Other Ventilation Parameters
기간: Up to 14 days during mechanical ventilation
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Peripheral oxygen saturation
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Up to 14 days during mechanical ventilation
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Other Ventilation Parameters
기간: Up to 14 days during mechanical ventilation
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Arterial blood gas parameters
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Up to 14 days during mechanical ventilation
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Need for Tracheostomy
기간: daily up to 14 days from inclusion
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Need for tracheostomy, first tracheostomy will be assessed up to 14 days from inclusion
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daily up to 14 days from inclusion
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Daily Lung Injury Scores
기간: Up to 14 days during mechanical ventilation
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Score based on chest X-ray findings (if obtained), PaO2/FiO2, PEEP level and respiratory compliance.
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Up to 14 days during mechanical ventilation
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Daily Sequential Organ Failure Assessment (SOFA)-scores
기간: Daily up to 14 days from inclusion
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six-organ dysfunction/failure score measuring multiple organ failure daily
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Daily up to 14 days from inclusion
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Complications
기간: Daily up to 14 days from inclusion
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Complications will include: Skin and soft tissue infections
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Daily up to 14 days from inclusion
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Complications
기간: Daily up to 14 days from inclusion
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Complications will include: (Ventilator associated) Pneumonia
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Daily up to 14 days from inclusion
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Complications
기간: Daily up to 14 days from inclusion
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Complications will include: Sepsis
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Daily up to 14 days from inclusion
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Complications
기간: Daily up to 14 days from inclusion
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Complications will include: Acute respiratory distress syndrome according to Berlin criteria
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Daily up to 14 days from inclusion
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Complications
기간: Daily up to 14 days from inclusion
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Complications will include: Acute renal failure
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Daily up to 14 days from inclusion
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Complications
기간: Daily up to 14 days from inclusion
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Complications will include: Abdominal compartment syndrome
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Daily up to 14 days from inclusion
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Standard care strategies
기간: Daily up to 14 days from inclusion
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Strategies considered to be important in patients who receive ventilation, including: Fluid balance, types and dose of fluids used
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Daily up to 14 days from inclusion
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Standard care strategies
기간: Daily up to 14 days from inclusion
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Strategies considered to be important in patients who receive ventilation, including: use of sedative and analgesic drugs
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Daily up to 14 days from inclusion
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Standard care strategies
기간: Daily up to 14 days from inclusion
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Strategies considered to be important in patients who receive ventilation, including: use of sedation and delirium scores
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Daily up to 14 days from inclusion
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Standard care strategies
기간: Daily up to 14 days from inclusion
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Strategies considered to be important in patients who receive ventilation, including: use of neuromuscular blocking agents
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Daily up to 14 days from inclusion
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Standard care strategies
기간: Daily up to 14 days from inclusion
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Strategies considered to be important in patients who receive ventilation, including: use of antibiotic prophylaxis
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Daily up to 14 days from inclusion
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공동 작업자 및 조사자
수사관
- 수석 연구원: Marcus J. Schultz, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
No intervention에 대한 임상 시험
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Otsuka Pharmaceutical Factory, Inc.Celerion완전한
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