de Wit Marjolein, Gennings Chris, Jenvey Wendy I, Epstein Scott K
Pulmonary and Critical Care Division, Department of Internal Medicine, School of Medicine, Virginia Commonwealth University, PO Box 980050, Richmond, VA 23298-0050, USA.
Crit Care. 2008;12(3):R70. doi: 10.1186/cc6908. Epub 2008 May 20.
Daily interruption of sedation (DIS) and sedation algorithms (SAs) have been shown to decrease mechanical ventilation (MV) duration. We conducted a randomized study comparing these strategies.
Mechanically ventilated adults 18 years old or older in the medical intensive care unit (ICU) were randomly assigned to DIS or SA. Exclusion criteria were severe neurocognitive dysfunction, administration of neuromuscular blockers, and tracheostomy. Study endpoints were total MV duration and 28-day ventilator-free survival.
The study was terminated prematurely after 74 patients were enrolled (DIS 36 and SA 38). The two groups had similar age, gender, racial distribution, Acute Physiology and Chronic Health Evaluation II score, and reason for MV. The Data Safety Monitoring Board convened after DIS patients were found to have higher hospital mortality; however, no causal connection between DIS and increased mortality was identified. Interim analysis demonstrated a significant difference in primary endpoint, and study termination was recommended. The DIS group had longer total duration of MV (median 6.7 versus 3.9 days; P = 0.0003), slower improvement of Sequential Organ Failure Assessment over time (0.70 versus 0.23 units per day; P = 0.025), longer ICU length of stay (15 versus 8 days; P < 0.0001), and longer hospital length of stay (23 versus 12 days; P = 0.01).
In our cohort of patients, the use of SA was associated with reduced duration of MV and lengths of stay compared with DIS. Based on these results, DIS may not be appropriate in all mechanically ventilated patients.
ClinicalTrials.gov NCT00205517.
每日中断镇静(DIS)和镇静算法(SA)已被证明可缩短机械通气(MV)时间。我们进行了一项随机研究以比较这些策略。
医学重症监护病房(ICU)中18岁及以上的机械通气成年患者被随机分配至DIS组或SA组。排除标准为严重神经认知功能障碍、使用神经肌肉阻滞剂和气管切开术。研究终点为总MV时间和28天无呼吸机生存。
在纳入74例患者(DIS组36例,SA组38例)后,研究提前终止。两组在年龄、性别、种族分布、急性生理与慢性健康状况评分II以及MV原因方面相似。在发现DIS组患者的医院死亡率较高后,数据安全监测委员会召开会议;然而,未确定DIS与死亡率增加之间的因果关系。中期分析显示主要终点存在显著差异,建议终止研究。DIS组的总MV时间更长(中位数6.7天对3.9天;P = 0.0003),序贯器官衰竭评估随时间的改善较慢(每天0.70对0.23单位;P = 0.025),ICU住院时间更长(15天对8天;P < 0.0001),医院住院时间更长(23天对12天;P = 0.01)。
在我们的患者队列中,与DIS相比,SA的使用与MV时间和住院时间的缩短相关。基于这些结果,DIS可能并非适用于所有机械通气患者。
ClinicalTrials.gov NCT00205517。