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监测声门下二氧化碳水平以优化机械通气患者气管导管套囊压力:随机对照试验

 罂粟花anesthGH 2021-07-21

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Optimization of Endotracheal Tube Cuff Pressure by Monitoring CO2 Levels in the Subglottic Space in Mechanically Ventilated Patients: A Randomized Controlled Trial

背景与目的

机械通气的许多并发症与气管插管(ETT)套囊压力不适当有关。 本研究的目的是评估长时间插管患者自动套囊压力闭环控制的有效性,其中声门下出现二氧化碳(CO2)作为泄漏指标。 研究的主要结果是使用CO2泄漏随时间曲线下的面积(AUC)量化的套囊周围渗漏量。

方  法

这是一项多中心,前瞻性,随机对照,非劣效性试验,包括重 症监护病房。 所有患者均插入AnapnoGuard ETT,其具有用于监测声门下空间中二氧化碳水平的 额外管腔。 研究组与AnapnoGuard系统连接,根据声门CO2(自动组)自动调整套囊控制。对照组连接到AnapnoGuard系统,套囊压力使用压力计3次/ d (手动组)手动管理。 由系统记录了两组袖带二氧化碳泄漏。                                                                    

结  果

纳入了72名患者,最终分析了64名患者。 每小时套囊二氧化碳泄漏(mm Hg AUC / h)为0.22±0.32,自动组为0.09±0.04(P = 0.01),其中下限单侧95%置信区间为0.05,显示非劣效(> -0.033)。 另外,双侧95%置信区间为0.010至0.196,显示优势(> 0.0)。 自发组中显着的二氧化碳排泄(CO2> 2 mm Hg)为0.027±0.057(mm Hg AUC / h),手术组为0.296±0.784(mm Hg AUC / h)(P = 0.025)。 此外,自动组的套囊压力的97.6%在预定安全范围内,而自动组为48.2%  (P <.001)。        


结  论

本研究表明,自动套囊压力组不仅具有非劣性而且比手动套囊压力组更优越。 因此,使用基于声门测量CO2水平的自动套囊压力控制是气管导管套囊压力优化的有效方法。 该方法是安全的,并且可以容易地与任何插管患者一起使用。

原始文献摘要

Morse J C, Huang J, Khona N, et al. Up-regulation of Intracellular Calcium Handling Underlies the Recovery of Endotoxemic Cardiomyopathy in Mice.[J]. Anesthesiology, 2017,126(6):1125-1138. DOI:10.1097/ALN.0000000000001627

BACKGROUND: Many of the complications of mechanical ventilation are related to inappropriate endotracheal tube (ETT) cuff pressure. The aim of the current study was to evaluate the effectiveness of automatic cuff pressure closed-loop control in patients under prolonged intubation, where presence of carbon dioxide (CO2) in the subglottic space is used as an indicator for leaks. The primary outcome of the study is leakage around the cuff quantified using the area under the curve (AUC) of CO2 leakage over time.

METHODS: This was a multicenter, prospective, randomized controlled, noninferiority trial including intensive care unit patients. All patients were intubated with the AnapnoGuard ETT, which has an extra lumen used to monitor CO2 levels in the subglottic space.The study group was connected to the AnapnoGuard system operating with cuff control adjusted automatically based on subglottic CO2 (automatic group). The control group was connected to the AnapnoGuard system, while cuff pressure was managed manually using a manometer 3 times/d (manual group). The system recorded around cuff CO2 leakage in both groups.

RESULTS: Seventy-two patients were recruited and 64 included in the final analysis. The mean hourly around cuff CO2 leak (mm Hg AUC/h) was 0.22 ± 0.32 in the manual group and 0.09 ± 0.04 in the automatic group (P = .01) where the lower bound of the 1-sided 95% confidence interval was 0.05, demonstrating noninferiority (>−0.033). Additionally, the 2-sided 95% confidence interval was 0.010 to 0.196, showing superiority (>0.0) as well. Significant CO2 leakage (CO2 >2 mm Hg) was 0.027 ± 0.057 (mm Hg AUC/h) in the automatic group versus 0.296 ±0.784 (mm Hg AUC/h) in the manual group (P = .025). In addition, cuff pressures were in the predefined safety range 97.6% of the time in the automatic group compared to 48.2% in the automatic group (P < .001).

CONCLUSIONS: This study shows that the automatic cuff pressure group is not only noninferior but also superior compared to the manual cuff pressure group. Thus, the use of automatic cuff pressure control based on subglottic measurements of CO2 levels is an effective method for ETT cuff pressure optimization. The method is safe and can be easily utilized with any intubated

patient. (Anesth Analg 2017;125:1309–15)

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