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)

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

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. 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. 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. ClinicalTrials.gov NCT02983851 . Registered 2 September 2016.