2024-513530-37-00招募中3 期
Comparison of an inhaled sedation strategy with an intravenous sedation strategy in intensive care patients treated with invasive mechanical ventilation: INASED study
Centre Hospitalier Regional Et Universitaire De Brest10 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年8月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 10
- 主要终点
- Occurrence (yes/no) of delirium in intensive care unit
研究概览
简要总结
Determine the impact on the frequency of delirium occurrence of an early inhaled sedation strategy (from induction in rapid sequence if intubated in the ICU, or from admission if intubated in the pre-hospital setting) with Isoflurane using an ANACONDA™-type system, compared with a conventional intravenous sedation strategy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 and over
- •Patient requires mechanical ventilation for at least 24 hours
- •Patient requires immediate continuous sedation for comfort, safety and to facilitate the administration of life-sustaining measures.
- •Consent obtained from patient or relative
排除标准
- •Patient admitted for the following reasons : - Cardiac arrest - Refractory status epilepticus - Moderate to severe head trauma - Cerebrovascular accident
- •Pregnant or breast-feeding women
- •Patient not affiliated to the social security system
- •Auditory or visual impairment, or aphasia prior to inclusion, making CAM-ICU impossible to perform
- •Sedation for more than 24 hours
- •Impaired cognitive function and/or dementia
- •Contraindication to halogenated gas (personal or family history of malignant hyperthermia, acute or chronic neuromuscular disease, hepatocellular insufficiency with TP<30%)
- •Severe ARDS (Berlin criteria: PaO2/FiO2<100 after ventilatory optimization)
- •PaCO2 at inclusion > 50 mmHg with pH<7.2 after ventilatory optimization
- •Patient for whom a "limitation of active therapies" procedure is envisaged on inclusion
- •Patient under guardianship or curatorship
结局指标
主要结局
Occurrence (yes/no) of delirium in intensive care unit
Occurrence (yes/no) of delirium in intensive care unit
次要结局
- ICU mortality, D28 mortality
- - Length of stay in intensive care
- - Number of days living without mechanical ventilation in intensive care at D28
- - CAM-ICU scale (2 times/day)
- - The quality of sedation is defined by: compliance (yes/no) with the sedation target (sedation score set as the target when prescribing)
- - Need for additional medication to alleviate agitation (yes/no, and if yes neuroleptic, benzodiazepine, dexmedetomidine)
- - Need for additional physical restraint to alleviate a state of agitation (yes/no)
- - Number of accidental removals by the patient of intubation tubes, vascular access tubes, nasogastric tubes and urinary catheters, based on the number of days in intensive care.
- - Number of self- or hetero-aggressive acts per number of days in intensive care
- - Average hospital costs per patient
- - Daily and cumulative dose of sedative
- - Cognitive consequences will be assessed. Calculation of CDR and IQCODE scores. Cognitive, psychological and quality of life assessment at 3 and 12 months.
研究者
Clinical trial project manager
Scientific
Centre Hospitalier Regional Et Universitaire De Brest
研究点 (10)
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