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)

BMC Pulmonary Medicine

Study Protocol

Dongshan Zhang¹  Xudong Xiang¹  Jinli Liao²  Hong Zhan²  Bo Wang³  Yong Li³  Yongli Miao⁴  Wenzhong Zhang⁴  Jingsong Zhang⁵  Xufeng Chen⁵  Qingming Lin⁶  Jun Ke⁶  Feng Chen⁶  Lishan Yang⁷  Jiali Wu⁷  Jingjun Lv⁸  Jie Wei⁸  Xiufeng Xie⁹  Fengying Chen⁹  Hong Zhang^1,10  Yun Zheng^1,10  Fengping Wang^1,11  Ying Deng^1,11  Kun He^1,12  Gang Liu^1,13  Meng Wang^1,14  Rong Zhu^1,15  Xiaohong Yu^1,16  Weiqin Wei^1,16  Guofeng Wu^1,16  Bo Li^1,17  Chuanyun Qian^1,17  Yanxia Gao^1,18  Li Li^1,18  Xianquan Liang^1,19  Yi Li^2,20  Shengyong Xu^2,20  Huadong Zhu^2,20  Tao Wang^2,20  Jianqiang He^2,20  Xin Lu^2,20  Yong Ma^2,20  Xuezhong Yu^2,20  Zongru Li^2,20  Dongqi Yao^2,21  Yingping Tian^2,21  Muming Yu^2,22  Yanfen Chai^2,22  Songtao Shou^2,22  Michael Eddleston^2,23 

[1] Department of Emergency Medicine, Second Xiangya Hospital, Institute of Emergency Medicine and Difficult Diseases, Central South University, Changsha, China;Department of Emergency Medicine, The First Affiliated Hospital of SUN Yat-sen University, Guangzhou, China;Department of Emergency, Cangzhou City Center Hospital, Cangzhou, China;Department of Emergency, First Hospital of Handan City, Handan, China;Department of Emergency, First affiliated hospital of Nanjing Medical University, Nanjing, China;Department of Emergency, Fujian Provincial Hospital, Provincial Clinical Medical College of Fujian Medical University, Fuzhou, China;Department of Emergency, General Hospital of Ningxia Medical University, Yinchuan, China;Department of Emergency, Renmin Hospital of Wuhan University, Wuhan, China;Department of Emergency, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China;Department of Emergency, The First Affiliated Hospital of Anhui Medical University, Hefei, China;Department of Emergency, The Second Affiliated Hospital of Harbin Medical University, Harbin, China;Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China;Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China;Department of Science and Technology, Beijing Tiantan Hospital, Capital Medical University, 100050, Beijing, China;Department of Ultrasound, Peking Union Medical College Hospital, Beijing, China;Emergency Department, Affiliated Hospital of Guizhou Medical University, Guiyang, China;Emergency Department, First Affiliated Hospital of Kunming Medical University, Kunming, China;Emergency Department, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China;Emergency Department, Guiyang Second People Hospital, Guiyang, China;Emergency Department, Peking Union Medical College Hospital, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China;Emergency Department, Second Hospital of Hebei Medical University, Shijiazhuang, China;Emergency Department, Tianjin Medical University General Hospital, Tianjin, China;Pharmacology, Toxicology and Therapeutics, Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK;

关键词: Ventilation strategy;    Noninvasive mechanical ventilation;    Invasive mechanical ventilation;    Acute respiratory failure;    Immunocompromised patients;   

DOI  :  10.1186/s12890-017-0467-6

 received in 2017-05-22, accepted in 2017-08-31,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundAcute 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 analysisThe 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.DiscussionVENIM 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 registrationClinicalTrials.gov NCT02983851. Registered 2 September 2016.

【 授权许可】

CC BY   
© The Author(s). 2017