Assessment of Automatic Relays by Intensive Basis Advantage Compared With Manual Relays, on the Hypotension Risks, During Noradrenalin Administration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Hypotension occurence defined as a decrease of 20% of the medium arterial pressure(MAP) between the baseline (MAP before the relay) and the minimal MAP in the fifteen minutes after the relay.
研究概览
简要总结
Circulatory failures are the main cause of admissions in the intensive care unit. It is recommended to prescribe to these patients an intravenous injection of catecholamine to correct this dysfunction and to keep an hemodynamic stability. Electric pumps are used to administrate a continuous flow of drugs to patient. When a syringe of drugs ends, it is replaced by a full syringe, it is named "relay". This change may cause a flow interruption and hypotension.
In the intensive care unit at departmental hospital (CHD) Vendee, the manual relays used in common practice will cause hemodynamic instabilities : hypotensions in 20% cases. Since 4 years, new devices are also used to make the relays. It is "smart pumps" allowing to manage automated the drug delays. This new method allows to not interrupt the drug flow. It could reduce the occurence of hypotension. A 50% decrease of relative number of hypotension will show that the use of automatic method is the most sure medical strategy.
Our study want to compare manual and automatic method watching the variations of medium arterial pressure (MAP) during the fifteen minutes after the relay compared to baseline (MAP before the relay). Noradrenalin is the catecholamine most administrated so we choose to study only the relay for this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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 > 18 years,
- •Patient receiving only noradrenalin as catecholamine,
- •Collection of patient's non-objection or his trustworthy person, if appropriate.
排除标准
- •Pregnant or breast feeding patient,
- •Patient receiving an other treatment on the catecholamine way,
- •No affiliation at a social security,
- •Refusal of patient's trustworthy person or parent, if the patient is unable to give his non-objection.
- •Refusal of patient's participation when he is conscious,
- •Subjects deprived of liberty, under guardianship, hospitalized in a health facility or social or hospitalized without their consent,
- •Patients with secreting tumor, kind pheochromocytoma ou carcinoid tumor.
结局指标
主要结局
Hypotension occurence defined as a decrease of 20% of the medium arterial pressure(MAP) between the baseline (MAP before the relay) and the minimal MAP in the fifteen minutes after the relay.
时间窗: every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
次要结局
- Number of relays where the medium arterial pressure (MAP) is decreased by 10% compared to baseline(every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay)
- Number of relays where the medium arterial pressure (MAP) is inferior to 50 millimeter of mercury (mmHg)(during the fifteen minutes after the relay)
- Number of hypotension in patients whose dose of noradrenalin is > 0,5 gamma/kg/min(every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay)