Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation : INASED Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 24
- 主要终点
- Occurrence of a delirium in intensive care
研究概览
简要总结
The objective of the study is to determine the impact on the frequency of occurrence of delirium of an early inhaled sedation strategy (from induction in rapid sequence if intubation in intensive care, or from admission if intubated in pre -hospital) by Isoflurane using an ANACONDA ™ type system, compared to a conventional intravenous sedation strategy.
详细描述
Sedation-analgesia is used in most patients treated with mechanical ventilation (MV). The usual benzodiazepine and morphine sedation reduces pain and anxiety and allows tolerance of invasive procedures in intensive care. These molecules, used as part of the sedation titration protocol or the daily sedation stop protocol, have improved patient outcomes.
Although necessary, these drugs, by mechanisms still uncertain, would promote the occurrence of resuscitation delirium. Delirium itself responsible for worsening morbidity and mortality (increase in the duration of MV, increase in the length of hospital stay, discussed increase in mortality, long-term cognitive sequelae).
This finding favored the use of new drugs in the sedation strategies of patients on MV. Dexmedetomidine has for example reduced the number of days of delirium, the number of days of coma and even mortality in septic patients. Its large-scale use has however been questioned by a recent study.
Halogenated gases have been used for a long time in anesthesia. Their pharmacodynamics, their positive and adverse effects, their therapeutic margins are well known. Thanks to technical innovations they can be used on resuscitation respirators. Several studies on targeted populations have shown the feasibility and the benefits of this use, in particular, the absence of accumulation, the absence of tachyphylaxis, the broad therapeutic range, the small interindividual variation, the rapidity of efficacy and the speed of awakening. Safety in use for the staff in charge of the patient is established. In addition, their potential neuroprotective effect would make it an anesthetic of choice in the prevention of resuscitation delirium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Patient aged 18 and over
- •Patient requiring mechanical ventilation for at least 24 hours
- •The patient requires continuous and immediate sedation for more comfort, safety and to facilitate the administration of survival measures.
- •Consent obtained from patient or relative
排除标准
- •Patient hospitalized for the following reasons for admission:
- •Cardiac arrest
- •State of refractory epilepticus
- •Head trauma
- •Hearing, visual or aphasia disorders before inclusion making it impossible to take the CAM-ICU
- •Sedation started more than 24 hours ago
- •Impairment of cognitive functions and / or dementia
- •Contraindication to halogenated gases (personal or family history of malignant hyperthermia, acute or chronic neuromuscular disease, hepatocellular insufficiency with PT <30%)
- •Severe acute respiratory distress syndrome (ARDS) (Berlin criteria: PaO2 / FiO2 <100 after ventilatory optimisation))
- •PaCO2 at inclusion> 50 mmHg after ventilatory optimisation
- •Patient for whom a procedure of "limitation of active therapies" is envisaged at inclusion
- •Patient under guardianship or curatorship
- •Minor patient
- •Pregnant or breastfeeding woman
- •Patient not affiliated to the social security scheme
研究组 & 干预措施
Usual sedation
Sedation according to a written, standardized Nurse management protocol using at least one sedative drug (propofol) and one analgesic drug.
干预措施: Propofol + analgesic drug (Drug)
Inhaled sedation
Sedation by inhalation of halogenated gas (Isoflurane) delivered by the Anesthetic-Conserving Device (ACD) system ANACONDA ™ associated with the administration of an analgesic drug.
干预措施: Isoflurane + analgesic drug (Drug)
结局指标
主要结局
Occurrence of a delirium in intensive care
时间窗: 28 days
Occurrence of delirium in intensive care will be observed (yes / no)
次要结局
- Incidence of delirium(28 days)
- Mortality in intensive care(Throuh exit from the intensive care unit, an average of 28 days)
- Mortality at day 28(28 days)
- Hospital cost per patient(Through study completion, an average of 1 year.)
- Number of days with vasopressors or inotropic agents(Throuh exit from the intensive care unit, an average of 28 days)
- Duration of delirium(28 days)
- Requirement of patients physical restraints(Throuh exit from the intensive care unit, an average of 28 days)
- Duration of anesthetics drugs(Throuh exit from the intensive care unit, an average of 28 days)
- Length of ICU stay(Throuh exit from the intensive care unit, an average of 28 days)
- Hetero-aggressive act(Throuh exit from the intensive care unit, an average of 28 days)
- Number of days with sedation(Throuh exit from the intensive care unit, an average of 28 days)
- Cumulative dose anesthetics drugs(Throuh exit from the intensive care unit, an average of 28 days)
- Maximum dose of vasopressors or inotropic agents(Throuh exit from the intensive care unit, an average of 28 days)
- Ventilation free days at 28 days following randomisation(28 days)
- Self aggressive act(Throuh exit from the intensive care unit, an average of 28 days)
- Evaluation of cognitive functions(Through study completion, an average of 1 year.)