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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Zuid Holland
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Amsterdam、Zuid Holland、オランダ、1105AZ
- Academic Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Ventilation parameters
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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90日目のICU滞在期間
時間枠：90日目まで
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入院から退院または死亡までの時間
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90日目まで
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90日目の入院期間
時間枠：90日目まで
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入院から退院または死亡までの時間
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90日目まで
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全死因による ICU 死亡率
時間枠：90日目まで
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ICU滞在中の死亡
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90日目まで
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全原因による病院死亡率
時間枠：90日目まで
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入院中に死亡した場合
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90日目まで
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Number of ventilator-free days and alive at day 28
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Standard care strategies
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Marcus J. Schultz, MD, PhD、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
No interventionの臨床試験
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University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
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University of MichiganNational Institute on Drug Abuse (NIDA)募集
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University of PittsburghCenters for Disease Control and Preventionまだ募集していません暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺