De Pascale Gennaro, Pennisi Mariano Alberto, Vallecoccia Maria Sole, Bello Giuseppe, Maviglia Riccardo, Montini Luca, Di Gravio Valentina, Cutuli Salvatore Lucio, Conti Giorgio, Antonelli Massimo
Department of Anesthesiology and Intensive Care, Sacro Cuore Catholic University, A. Gemelli Hospital, Rome, Italy.
PLoS One. 2017 May 11;12(5):e0175476. doi: 10.1371/journal.pone.0175476. eCollection 2017.
To determine the safety and clinical efficacy of an innovative integrated airway system (AnapnoGuard™ 100 system) that continuously monitors and controls the cuff pressure (Pcuff), while facilitating the aspiration of subglottic secretions (SS).
This was a prospective, single centre, open-label, randomized, controlled feasibility and safety trial. The primary endpoint of the study was the rate of device related adverse events (AE) and serious AE (SAE) as a result of using AnapnoGuard (AG) 100 during mechanical ventilation. Secondary endpoints were: (1) mechanical complications rate (2) ICU staff satisfaction; (3) VAP occurrence; (4) length of mechanical ventilation; (5) length of Intensive Care Unit stay and mortality; (6) volume of evacuated subglottic secretions. Sixty patients were randomized to be intubated with the AG endotracheal-tube (ETT) and connected to the AG 100 system allowing Pcuff adjustment and SS aspiration; or with an ETT combined with SS drainage and Pcuff controlled manually.
No difference in adverse events rate was identified between the groups. The use of AG system was associated with a significantly higher incidence of Pcuff determinations in the safety range (97.3% vs. 71%; p<0.01) and a trend to a greater volume of aspirated SS secretions: (192.0[64-413] ml vs. 150[50-200], p = 0.19 (total)); (57.8[20-88.7] ml vs. 50[18.7-62] ml, p = 0.11 (daily)). No inter-group difference was detected using AG system vs. controls in terms of post-extubation throat pain level (0 [0-2] vs. 0 [0-3]; p = 0.7), hoarseness (42.9% vs. 75%; p = 0.55) and tracheal mucosa oedema (16.7% vs. 10%; p = 0.65). Patients enrolled in the AG group had a trend to reduced VAP risk of ventilator-associated pneumonia(VAP) (14.8% vs. 40%; p = 0.06), which were more frequently monomicrobial (25% vs. 70%; p = 0.03). No statistically significant difference was observed in duration of mechanical ventilation, ICU stay, and mortality.
The use AG 100 system and AG tube in critically ill intubated patients is safe and effective in Pcuff control and SS drainage. Its protective role against VAP needs to be confirmed in a larger randomized trial.
ClinicalTrials.gov NCT01550978. Date of registration: February 21, 2012.
确定一种创新的集成气道系统（AnapnoGuard™ 100系统）的安全性和临床疗效，该系统可连续监测和控制套囊压力（Pcuff），同时便于吸引声门下分泌物（SS）。
这是一项前瞻性、单中心、开放标签、随机对照的可行性和安全性试验。该研究的主要终点是在机械通气期间使用AnapnoGuard（AG）100导致的与设备相关的不良事件（AE）和严重不良事件（SAE）发生率。次要终点包括：（1）机械并发症发生率；（2）重症监护病房（ICU）工作人员满意度；（3）呼吸机相关性肺炎（VAP）的发生情况；（4）机械通气时间；（5）ICU住院时间和死亡率；（6）吸出的声门下分泌物量。60例患者被随机分组，分别使用AG气管内导管（ETT）并连接到AG 100系统以允许调整Pcuff和吸引SS，或使用结合了SS引流和手动控制Pcuff的ETT。
两组之间在不良事件发生率上未发现差异。使用AG系统与安全范围内Pcuff测定的发生率显著更高相关（97.3%对71%；p<0.01），并且吸出的SS分泌物量有增加的趋势：（总量：192.0[64 - 413]毫升对150[50 - 200]毫升，p = 0.19）；（每日：57.8[20 - 88.7]毫升对50[18.7 - 62]毫升，p = 0.11）。在拔管后咽痛水平（0[0 - 2]对0[0 - 3]；p = 0.7）、声音嘶哑（42.9%对75%；p = 0.55）和气管黏膜水肿（16.7%对10%；p = 0.65）方面，AG系统与对照组之间未检测到组间差异。AG组患者有降低VAP风险的趋势（14.8%对40%；p = 0.06），且VAP更常为单一微生物感染（25%对70%；p = 0.03）。在机械通气时间、ICU住院时间和死亡率方面未观察到统计学显著差异。
在重症插管患者中使用AG 100系统和AG导管在控制Pcuff和引流SS方面是安全有效的。其对VAP的保护作用需要在更大规模的随机试验中得到证实。
ClinicalTrials.gov NCT01550978。注册日期：2012年2月21日。
