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比较脑电双频指数监测与临床评估在 ICU 中深度镇静的效果:对谵妄减少和镇静药物剂量的影响——一项随机试验。

Comparing Bispectral Index Monitoring vs Clinical Assessment for Deep Sedation in the ICU: Effects on Delirium Reduction and Sedative Drug Doses-A Randomized Trial.

机构信息

Hospital Italiano de Buenos Aires, Buenos Aires, Argentina; Universidad de Buenos Aires, Buenos Aires, Argentina.

Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.

出版信息

Chest. 2024 Oct;166(4):733-742. doi: 10.1016/j.chest.2024.05.031. Epub 2024 Jun 18.

DOI:10.1016/j.chest.2024.05.031
PMID:38901489
Abstract

BACKGROUND

Sedative overdoses pose a risk of delirium among patients in the ICU, with potential mitigation through the use of a processed EEG monitor (the bispectral index [BIS]) to guide depth of sedation.

RESEARCH QUESTION

Can BIS-guided deep sedation (Richmond Agitation Sedation Scale [RASS] score, -4 or -5) reduce sedative dosage and increase delirium-free and coma-free (DFCF) days?

STUDY DESIGN AND METHODS

A randomized controlled trial was conducted in a tertiary mixed ICU, enrolling patients requiring deep sedation for > 8 h. Patients were assigned randomly to either the clinical assessment (CA) or BIS groups (BIS range, 40-60). Both groups used a BIS sensor, whereas the CA group's screen remained covered. After deep sedation, BIS sensors were removed, and delirium was assessed twice daily by researchers masked to the randomization. The primary outcome was the number of DFCF days within 14 days after deep sedation. Additionally, we compared doses of sedative drugs and BIS values during deep sedation.

RESULTS

Ninety-nine patients were included in the study. We found no significant difference in DFCF days (P = .1) between CA and BIS arms, but propofol doses were significantly lower in the BIS group (CA group, 1.77 mg/kg/h [95% CI, 1.60-1.93] vs BIS group, 1.44 mg/kg/h [95% CI, 1.04-1.83]; P = .03). During deep sedation, the CA group spent 46% of the total hours (95% CI, 35%-57%) with BIS values of < 40, whereas the BIS group spent 32% (95% CI, 25%-40%; P = .03). Subgroup analysis focusing on patients sedated for > 24 h revealed an increase in DFCF days in the BIS group (CA group: median, 1 day [interquartile range, 0-9 days] vs BIS group: median, 8 days [interquartile range, 0-13 days]; P = .04).

INTERPRETATION

In this study, BIS-guided deep sedation did not improve DFCF days, but did reduce sedative drug use. In patients requiring sedation for > 24 h, it showed an improvement in DFCF days.

TRIAL REGISTRY

ClinicalTrials.gov; No.: NCT03840577; URL: www.

CLINICALTRIALS

gov.

摘要

背景

镇静剂过量会导致 ICU 患者出现谵妄,通过使用经过处理的脑电图监测仪(双频谱指数[BIS])来指导镇静深度,可能会减轻这种风险。

研究问题

BIS 引导的深度镇静(Richmond 激动-镇静评分[RASS]评分,-4 或-5)是否可以减少镇静剂剂量并增加无镇静剂和无昏迷(DFCF)天数?

研究设计和方法

在一家三级混合 ICU 中进行了一项随机对照试验,纳入需要深度镇静超过 8 小时的患者。患者被随机分配到临床评估(CA)或 BIS 组(BIS 范围,40-60)。两组均使用 BIS 传感器,而 CA 组的屏幕被遮盖。深度镇静后,去除 BIS 传感器,研究人员对接受随机分组的患者进行每日两次的谵妄评估。主要结局是在深度镇静后 14 天内 DFCF 天数。此外,我们比较了镇静药物剂量和深度镇静期间的 BIS 值。

结果

共有 99 名患者纳入研究。我们没有发现 CA 组和 BIS 组在 DFCF 天数上有显著差异(P=0.1),但 BIS 组的丙泊酚剂量明显较低(CA 组:1.77mg/kg/h[95%CI,1.60-1.93]vs BIS 组:1.44mg/kg/h[95%CI,1.04-1.83];P=0.03)。在深度镇静期间,CA 组有 46%(95%CI,35%-57%)的总时间 BIS 值<40,而 BIS 组有 32%(95%CI,25%-40%;P=0.03)。针对镇静时间超过 24 小时的患者的亚组分析显示,BIS 组的 DFCF 天数增加(CA 组:中位数 1 天[四分位距,0-9 天]vs BIS 组:中位数 8 天[四分位距,0-13 天];P=0.04)。

结论

在这项研究中,BIS 指导的深度镇静并未改善 DFCF 天数,但确实减少了镇静药物的使用。在需要镇静超过 24 小时的患者中,它显示出 DFCF 天数的改善。

试验注册

ClinicalTrials.gov;编号:NCT03840577;网址:www.clinicaltrials.gov。

临床试验

www.clinicaltrials.gov。

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