Sevoflurane pharmacokInetics During Inhaled Sedation Relies on the Morphotype of ARDS in ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 37
- 试验地点
- 3
- 主要终点
- Plasma concentrations of sevoflurane
研究概览
简要总结
The main objective of this study is to compare the pharmacokinetic models of sevoflurane-induced sedation during ARDS depending on the lung imaging phenotype (focal vs nonfocal phenotypes) The authors hypothesized that sevoflurane used for inhaled sedation could have distinct pharmacokinetic profiles depending on lung imaging phenotypes (focal vs nonfocal) during ARDS in ICU patients.
详细描述
Adult patients admitted to the ICU within 12 hours of moderate-severe ARDS onset and under sedation with sevoflurane will be enrolled in the study with inclusion criteria. They will be enrolled, depending on their morphotype (focal or nonfocal), as routinely assessed in participating centers using CT-scan, chest x-ray and/or lung ultrasound.
These patients will receive inhaled sevoflurane as a standard practice of sedation that is routinely used in participating ICUs. After inclusion, the mechanical ventilation protocol must be initiated within two hours (if not already being used). In both groups, deep sedation followed by neuromuscular blockade must be initiated within four hours of inclusion.
Adult patients admitted to the ICU within 12 hours of moderate-severe ARDS onset and under sedation with sevoflurane will be enrolled in the study with inclusion criteria. They will be enrolled, depending on their morphotype (focal or nonfocal), as routinely assessed in participating centers using CT-scan, chest x-ray and/or lung ultrasound.
These patients will receive inhaled sevoflurane as a standard practice of sedation that is routinely used in participating ICUs. After inclusion, the mechanical ventilation protocol must be initiated within two hours (if not already being used). In both groups, deep sedation followed by neuromuscular blockade must be initiated within four hours of inclusion.
Blood sample will be collected at different times after the onset of sevoflurane administration and after its cessation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
It is an open label trial because the patients are included from a group depending to the morphotype of ARDS. However, all subsequent evaluations will be conducted by clinical research staff according to the attributed group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Presence for ≤ 12 hours of all of the following conditions, within one week of a clinical insult or new or worsening respiratory symptoms :
- •a PaO2/FiO2 < 200 mmHg with positive end-expiratory pressure (PEEP) ≥ 8 cmH2O (or, if arterial blood gas not available : SpO2/FiO2 ratio that is equivalent to a PaO2/FiO2 < 200 mmHg with PEEP ≥8 cmH2O, and a confirmatory SpO2/FiO2 ratio between 1-6 hours after the initial SpO2/FiO2 ratio determination) b Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules c Respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present
排除标准
- •Lack of informed consent
- •Continuous sedation with inhaled sevoflurane at enrollment
- •Currently receiving ECMO therapy
- •Chronic respiratory failure defined as PaCO2 > 60 mmHg in the outpatient setting
- •Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing
- •Body mass index > 40 kg/m2
- •Chronic liver disease defined as a Child-Pugh score of 12-15
- •Expected duration of mechanical ventilation < 48 hours
- •Tidal volume of 6 mL/kg predicted body weight (PBW) below 200 mL
- •Decision to withhold life-sustaining treatment; except in those patients committed to full support except cardiopulmonary resuscitation
- •Moribund patient, i.e. not expected to survive 24 hours despite intensive care
- •Burns > 70% total body surface
- •Previous hypersensitivity or anaphylactic reaction to sevoflurane
- •Medical history of malignant hyperthermia
- •Suspected or proven intracranial hypertension
- •Know pregnancy - Pregnancy testing will be systematically performed to rule out pregnancy in female patients of reproductive age
- •Enrollment in another interventional ARDS trial with direct impact on sedation and PEEP
- •Endotracheal ventilation for greater than 120 hours (5 days)
- •PaO2/FiO2 (if available) > 200 mmHg after meeting inclusion criteria and before start of the study
研究组 & 干预措施
Focal ARDS
ARDS patient with focal lung imaging phenotype
干预措施: Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNts (Drug)
Nonfocal ARDS
ARDS patient with nonfocal lung imaging phenotype
干预措施: Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNts (Drug)
结局指标
主要结局
Plasma concentrations of sevoflurane
时间窗: 6 hours after the cessation of sevoflurane administration
Plasma concentrations of sevoflurane
次要结局
- Fraction of inspired sevoflurane(Until sedation can be definitely interrupted or until day 7)
- Fraction of expired sevoflurane(Until sedation can be definitely interrupted or until day 7)
- Plasma concentration of hexafluoroisopropanolol(Until sedation can be definitely interrupted or until day 7)
- Dose of sevoflurane(Until sedation can be definitely interrupted or until day 7)
- Infusion duration of sevoflurane(Until sedation can be definitely interrupted or until day 7)
- Infusion rate of remifentanil(Until sedation can be definitely interrupted or until day 7)
- Values of a bispectral index(Until sedation can be definitely interrupted or until day 7)