BMC pulmonary medicine · 2017

The efficacy of initial ventilation strategy for adult immunocompromised patients with severe acute hypoxemic respiratory failure: study protocol for a multicentre randomized controlled trial (VENIM).

СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен

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Wang Tao, Liu Gang, He Kun, Lu Xin, Liang Xianquan, Wang Meng, Zhu Rong, Li Zongru, Chen Feng, Ke Jun, Lin Qingming, Qian Chuanyun, Li Bo, Wei Jie, Lv Jingjun, Li Li, Gao Yanxia, Wu Guofeng, Yu Xiaohong, Wei Weiqin, Deng Ying, Wang Fengping, Zhang Hong, Zheng Yun, Zhan Hong, Liao Jinli, Tian Yingping, Yao Dongqi, Zhang Jingsong, Chen Xufeng, Yang Lishan, Wu Jiali, Chai Yanfen, Shou Songtao, Yu Muming, Xiang Xudong, Zhang Dongshan, Chen Fengying, Xie Xiufeng, Li Yong, Wang Bo, Zhang Wenzhong, Miao Yongli, Eddleston Michael, He Jianqiang, Ma Yong, Xu Shengyong, Li Yi, Zhu Huadong, Yu Xuezhong

Аннотация

BACKGROUND: Acute respiratory failure (ARF) is still one of the most severe complications in immunocompromised patients. Our previous systematic review showed noninvasive mechanical ventilation (NIV) reduced mortality, length of hospitalization and ICU stay in AIDS/hematological malignancy patients with relatively less severe ARF, compared to invasive mechanical ventilation (IMV). However, this systematic review was based on 13 observational studies and the quality of evidence was low to moderate. The efficacy of NIV in more severe ARF and in patients with other causes of immunodeficiency is still unclear. We aim to determine the efficacy of the initial ventilation strategy in managing ARF in immunocompromised patients stratified by different disease severity and causes of immunodeficiency, and explore predictors for failure of NIV.

METHODS AND ANALYSIS: The VENIM is a multicentre randomized controlled trial (RCT) comparing the effects of NIV compared with IMV in adult immunocompromised patients with severe hypoxemic ARF. Patients who meet the indications for both forms of ventilatory support will be included. Primary outcome will be 30-day all-cause mortality. Secondary outcomes will include in-hospital mortality, length of stay in hospital, improvement of oxygenation, nosocomial infections, seven-day organ failure, adverse events of intervention, et al. Subgroups with different disease severity and causes of immunodeficiency will also be analyzed.

DISCUSSION: VENIM is the first randomized controlled trial aiming at assessing the efficacy of initial ventilation strategy in treating moderate and severe acute respiratory failure in immunocompromised patients. The result of this RCT may help doctors with their ventilation decisions.

TRIAL REGISTRATION: ClinicalTrials.gov NCT02983851 . Registered 2 September 2016.

The efficacy of initial ventilation strategy for adult immunocompromised patients with severe acute hypoxemic respiratory failure: study protocol for a multicentre randomized controlled trial (VENIM).

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