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Randomized Controlled Trial
. 2017 Sep 20;17(1):127.
doi: 10.1186/s12890-017-0467-6.

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  1 , Gang Liu  2 , Kun He  3 , Xin Lu  1 , Xianquan Liang  4 , Meng Wang  5 , Rong Zhu  6 , Zongru Li  1 , Feng Chen  7 , Jun Ke  7 , Qingming Lin  7 , Chuanyun Qian  8 , Bo Li  8 , Jie Wei  9 , Jingjun Lv  9 , Li Li  10 , Yanxia Gao  10 , Guofeng Wu  11 , Xiaohong Yu  11 , Weiqin Wei  11 , Ying Deng  12 , Fengping Wang  12 , Hong Zhang  13 , Yun Zheng  13 , Hong Zhan  14 , Jinli Liao  14 , Yingping Tian  15 , Dongqi Yao  15 , Jingsong Zhang  16 , Xufeng Chen  16 , Lishan Yang  17 , Jiali Wu  17 , Yanfen Chai  18 , Songtao Shou  18 , Muming Yu  18 , Xudong Xiang  19 , Dongshan Zhang  19 , Fengying Chen  20 , Xiufeng Xie  20 , Yong Li  21 , Bo Wang  21 , Wenzhong Zhang  22 , Yongli Miao  22 , Michael Eddleston  23 , Jianqiang He  1 , Yong Ma  1 , Shengyong Xu  1 , Yi Li  24 , Huadong Zhu  25 , Xuezhong Yu  26
Affiliations
Randomized Controlled Trial

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 et al. BMC Pulm Med. .

Abstract

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.

Keywords: Acute respiratory failure; Immunocompromised patients; Invasive mechanical ventilation; Noninvasive mechanical ventilation; Ventilation strategy.

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Conflict of interest statement

Ethics approval and consent to participate

The study protocol and informed consent documents have been approved by the Ethics Committees of Peking Union Medical College Hospital in Oct. 2016 (JS-1158) and the other 16 cooperating hospitals. The VENIM trial has been registered on Clinicaltrials.gov (NCT02983851). Participants/legal principals will be given an information sheet, time to fully understand it, and any questions answered. Withdrawal from the study at any time will in no way affect the care they receive from the hospitals later. Participant confidentiality will be ensured and anonymity guaranteed. Consent from all patients/legal principals must be obtained before enrollment, according to the Law of the People’s Republic of China. Serious adverse events (eg, unexpected death) and any other important events will be recorded and reported to the Ethics Committees of Peking Union Medical College Hospital.

A data and safety monitoring committee (DSMC) will be established, consisting of two physicians and one biostatistician independent of the present trial. DSMC is responsible for monitoring the safety data, evaluating the results of interim analysis, and providing with recommendations about whether the trial should continue, prolonged, or terminated prematurely.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Diagram of the study protocol according to CONSORT
Fig. 2
Fig. 2
Study design of the VENIM trial. ARF, acute respiratory failure; FiO2, fractional inspired oxygen; IMV, invasive mechanical ventilation; IPAP, inhale positive airway pressure; NIV, non-invasive ventilation; PEEP, positive end-expiratory pressure; VT, tidal volume. BiPAP, bi-level positive airway pressure
See this image and copyright information in PMC

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