Analgesia-First Sedation in Trauma Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Mechanical Ventilation days until successful extubation
研究概览
简要总结
The study's aim is to ascertain the best approach for providing sedation and pain management for patients who have sustained trauma and are requiring respiratory support from a mechanical ventilator. The common approach to patients who need mechanical ventilation is to provide continuous drips of sedatives and pain medicine and awaken the patient once a day to check the brain functions. Another approach is to provide pain medicine and reserve sedatives for only a short duration when needed. The difference between approaches has not been studied in Trauma patients.
详细描述
A significant proportion of patients admitted to the intensive care unit (ICU) require mechanical ventilation (MV). To facilitate care and maintain comfort for patients requiring MV, the utilization of a large quantity of sedatives and analgesics is required with either continuous infusion or intermittent dosing. However, prolonged continuous administration of sedatives and analgesics can contribute to prolonged MV. Numerous studies have shown that instituting protocol-directed sedation (PDS) by continuous infusion of sedatives and analgesics using a protocol that includes a daily interruption (DI) of the sedative will improve MV outcomes, specifically the duration of MV.
Protocol-directed sedation and daily sedation interruption:
Brook AD et al. performed a randomized, single-center, clinical trial; comparing protocol-directed sedation versus non-protocol-directed sedation in 321 mechanically ventilated patients. They included patients greater than the age of who were admitted to the medical intensive care unit. Based on randomization, 162 patients received protocol-directed sedation and 159 patients received non-protocol-directed sedation. The primary outcome measure was the duration of mechanical ventilation and secondary outcomes included: the length of ICU and hospital stay. The results revealed a reduction in the mean duration of mechanical ventilation for the protocol-directed sedation group (89.1 ± 133.6 hrs vs. 124.0 ± 153.6 hrs; p = .003). In addition, the protocol-directed sedation group had a reduced length of stay in the intensive care unit and hospital {5.7 ± 5.9 days vs. 7.5 ± 6.5 days (p = .013) and 14.0 ± 17.3 days vs. 19.9 ± 24.2 days (p < .001); respectively}. The protocol-directed sedation group (n = 66) had a reduced duration of continuous intravenous sedation (3.5 ± 4.0 days vs. 5.6 ± 6.4 days; p = .003). Brook's study demonstrated the clinical benefits of having protocol-directed or nurse-directed sedation in the medical intensive care unit. Since the study only involved patients in the medical intensive care unit, it is uncertain if the results are applicable to patients in the surgical unit.
Kress JP, et al. performed a randomized, single-center, clinical trial to evaluate daily interruption of continuous infusion of sedation in 128 mechanically ventilated adult patients. Notable exclusion criteria included patients already on sedative agents upon transfer to the ICU and admission due to resuscitation from cardiac arrest. The primary endpoints of the study included: the duration of mechanical ventilation, the length of stay in the intensive care unit, and the length of stay in the hospital. Total doses of sedatives (i.e. midazolam, propofol) and analgesic agents (i.e. morphine) were additional measured outcomes. Results from the study revealed a reduction in the median duration of mechanical ventilation for the daily interrupted group (4.9 vs. 7.3 days, p=.004). In addition, there was a reduction in the median length of stay in the ICU and hospital (6.4 vs. 9.9 days, p=.02 and 13.3 vs. 16.9 days, p=0.19; respectively). The total dose of midazolam was lesser in the daily interruption group (229.8 vs. 425.5 mg; p=.05). The study found no difference in regard to the incidence of self-extubation. Kress' study showed positive clinical outcomes with DI in the medical intensive care unit. However, many clinicians are concerned with the risk-related complications from DI (i.e. posttraumatic stress disorder and enhanced catecholamine response leading to cardiac complications). The study did contain limitations: it was limited to a single center and only included patients that were admitted to the medical intensive care unit. Thus, it is not clear if the results can be reproduced in other centers or applied to critically-ill surgical patients. Additionally, there was no mention of the use of PD-SBTs
Can analgesia first effectively facilitate mechanical ventilation for critically ill patients?
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
- •≥ 18 years of age
- •Mechanically ventilated with an expected duration of MV ≥ 48h
- •Initiated continuous sedative/analgesic infusions by the ICU team
- •Patient is a candidate for MV weaning
排除标准
- •Admission after resuscitation from cardiac arrest
- •Significant neurological deficit due to a chronic disorder
- •History of alcohol dependence and/or other illicit drug abuse
- •Prior administration of continuous sedative/analgesic from a transferring institution
- •Patient receiving neuromuscular blocking agents
- •Allergy to midazolam, lorazepam, and/or propofol
结局指标
主要结局
Mechanical Ventilation days until successful extubation
时间窗: 28 days
Duration of mechanical ventilation
次要结局
- Duration of MV weaning(28 days)
研究者
Maged Tanios, MD
Medical Director
MemorialCare Health System
