急性高碳酸血症呼吸衰竭患者采用容量目标通气与压力限制无创通气的多中心随机对照试验
Volume-Targeted Versus Pressure-Limited Noninvasive Ventilation in Subjects With Acute Hypercapnic Respiratory Failure: A Multicenter Randomized Controlled Trial.
作者信息
Cao Zhixin, Luo Zujin, Hou Anna, Nie Qingrong, Xie Baoyuan, An Xiaojie, Wan Zifen, Ye Xianwei, Xu Yanju, Chen Xisheng, Zhang Honghai, Xu Zhenyang, Wang Jinxiang, An Fucheng, Li Pengfei, Yu Chunxiao, Liang Yandong, Zhang Yongxiang, Ma Yingmin
机构信息
Department of Respiratory and Critical Care Medicine, Beijing Engineering Research Center of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
Department of Respiratory Medicine, Liangxiang Hospital of Beijing Fangshan District, Beijing, China.
出版信息
Respir Care. 2016 Nov;61(11):1440-1450. doi: 10.4187/respcare.04619. Epub 2016 Oct 18.
BACKGROUND
Volume-targeted noninvasive ventilation (VT-NIV), a hybrid mode that delivers a preset target tidal volume (V) through the automated adjustment of pressure support, could guarantee a relatively constant target V over pressure-limited noninvasive ventilation (PL-NIV) with fixed-level pressure support. Whether VT-NIV is more effective in improving ventilatory status in subjects with acute hypercapnic respiratory failure (AHRF) remains unclear. Our aim was to verify whether, in comparison with PL-NIV, VT-NIV would be more effective in correcting hypercapnia, hence reducing the need for intubation and improving survival in subjects with AHRF.
METHODS
We performed a prospective randomized controlled trial in the general respiratory wards of 8 university-affiliated hospitals in China over a 12-month period. Subjects with AHRF, defined as arterial pH <7.35 and ≥7.25 and P >45 mm Hg, were randomly assigned to undergo PL-NIV or VT-NIV. The primary end point was the decrement of P from baseline to 6 h after randomization. Secondary end points included the decrement of P from baseline to 2 h after randomization as well as outcomes of subjects (eg, need for intubation, in-hospital mortality).
RESULTS
A total of 58 subjects were assigned to PL-NIV (29 subjects) or VT-NIV (29 subjects) and included in the analyses. The decrement of P from baseline to 6 h after randomization was not statistically different between the PL-NIV group and the VT-NIV group (9.3 ± 12.6 mm Hg vs 11.7 ± 12.9 mm Hg, P = .48). There were no differences between the PL-NIV group and the VT-NIV group in the decrement of P from baseline to 2 h after randomization (6.4 ± 12.7 mm Hg vs 5.0 ± 15.8 mm Hg, P = .71) as well as in the need for intubation (17.2% vs 10.3%, P = .70), and in-hospital mortality (10.3% vs 6.9%, P > .99).
CONCLUSIONS
Regardless of whether a VT- or PL-NIV strategy is employed, it is possible to provide similar support to subjects with AHRF. (ClinicalTrials.gov registration NCT02538263.).
背景
容量目标无创通气（VT-NIV）是一种混合模式，通过自动调节压力支持来输送预设的目标潮气量（V），与固定水平压力支持的压力限制无创通气（PL-NIV）相比，它可以保证相对恒定的目标V。VT-NIV在改善急性高碳酸血症呼吸衰竭（AHRF）患者的通气状态方面是否更有效尚不清楚。我们的目的是验证与PL-NIV相比，VT-NIV在纠正高碳酸血症方面是否更有效，从而减少AHRF患者的插管需求并提高生存率。
方法
我们在中国8家大学附属医院的普通呼吸病房进行了一项为期12个月的前瞻性随机对照试验。将动脉pH<7.35且≥7.25以及P>45mmHg定义为AHRF的患者随机分配接受PL-NIV或VT-NIV。主要终点是随机分组后从基线到6小时P的下降。次要终点包括随机分组后从基线到2小时P的下降以及患者的结局（如插管需求、院内死亡率）。
结果
共有58名患者被分配到PL-NIV组（29名患者）或VT-NIV组（29名患者）并纳入分析。PL-NIV组和VT-NIV组在随机分组后从基线到6小时P的下降无统计学差异（9.3±12.6mmHg对11.7±12.9mmHg，P = 0.48）。PL-NIV组和VT-NIV组在随机分组后从基线到2小时P的下降（6.4±12.7mmHg对5.0±15.8mmHg，P = 0.71）、插管需求（17.2%对10.3%，P = 0.70）以及院内死亡率（10.3%对6.9%，P>.99）方面均无差异。
结论
无论采用VT-NIV还是PL-NIV策略，都有可能为AHRF患者提供相似的支持。（ClinicalTrials.gov注册号NCT02538263。）
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