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中等收入国家通气实践(PRoVENT-iMIC):一项针对亚洲重症监护病房的前瞻性国际多中心观察性研究的原理与方案

PRactice of VENTilation in Middle-Income Countries (PRoVENT-iMIC): rationale and protocol for a prospective international multicentre observational study in intensive care units in Asia.

作者信息

Pisani Luigi, Algera Anna Geke, Serpa Neto Ary, Ahsan Areef, Beane Abigail, Chittawatanarat Kaweesak, Faiz Abul, Haniffa Rashan, Hashemian Reza, Hashmi Madiha, Imad Hisham Ahmed, Indraratna Kanishka, Iyer Shivakumar, Kayastha Gyan, Krishna Bhuvana, Moosa Hassan, Nadjm Behzad, Pattnaik Rajyabardhan, Sampath Sriram, Thwaites Louise, Tun Ni Ni, Yunos Nor'azim Mohd, Grasso Salvatore, Paulus Frederique, de Abreu Marcelo Gama, Pelosi Paolo, Dondorp Arjen M, Schultz Marcus J

机构信息

Department of Intensive Care, Academic Medical Center, Amsterdam, The Netherlands.

Mahidol Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.

出版信息

BMJ Open. 2018 Apr 28;8(4):e020841. doi: 10.1136/bmjopen-2017-020841.

DOI:10.1136/bmjopen-2017-020841
PMID:29705765
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5931304/
Abstract

INTRODUCTION

Current evidence on epidemiology and outcomes of invasively mechanically ventilated intensive care unit (ICU) patients is predominantly gathered in resource-rich settings. Patient casemix and patterns of critical illnesses, and probably also ventilation practices are likely to be different in resource-limited settings. We aim to investigate the epidemiological characteristics, ventilation practices and clinical outcomes of patients receiving mechanical ventilation in ICUs in Asia.

METHODS AND ANALYSIS

PRoVENT-iMIC (study of PRactice of VENTilation in Middle-Income Countries) is an international multicentre observational study to be undertaken in approximately 60 ICUs in 11 Asian countries. Consecutive patients aged 18 years or older who are receiving invasive ventilation in participating ICUs during a predefined 28-day period are to be enrolled, with a daily follow-up of 7 days. The primary outcome is ventilatory management (including tidal volume expressed as mL/kg predicted body weight and positive end-expiratory pressure expressed as cm HO) during the first 3 days of mechanical ventilation-compared between patients at no risk for acute respiratory distress syndrome (ARDS), patients at risk for ARDS and in patients with ARDS (in case the diagnosis of ARDS can be made on admission). Secondary outcomes include occurrence of pulmonary complications and all-cause ICU mortality.

ETHICS AND DISSEMINATION

PRoVENT-iMIC will be the first international study that prospectively assesses ventilation practices, outcomes and epidemiology of invasively ventilated patients in ICUs in Asia. The results of this large study, to be disseminated through conference presentations and publications in international peer-reviewed journals, are of ultimate importance when designing trials of invasive ventilation in resource-limited ICUs. Access to source data will be made available through national or international anonymised datasets on request and after agreement of the PRoVENT-iMIC steering committee.

TRIAL REGISTRATION NUMBER

NCT03188770; Pre-results.

摘要

引言

目前关于侵入性机械通气重症监护病房(ICU)患者的流行病学和预后的证据主要来自资源丰富的环境。在资源有限的环境中,患者病例组合、危重病模式以及通气实践可能也有所不同。我们旨在调查亚洲ICU中接受机械通气患者的流行病学特征、通气实践和临床结局。

方法与分析

PRoVENT-iMIC(中等收入国家通气实践研究)是一项国际多中心观察性研究,将在11个亚洲国家的约60个ICU中进行。在预定的28天期间内,连续纳入参与ICU中接受有创通气的18岁及以上患者,并进行为期7天的每日随访。主要结局是机械通气前3天的通气管理(包括以预测体重的毫升数/千克表示的潮气量和以厘米水柱表示的呼气末正压),比较无急性呼吸窘迫综合征(ARDS)风险的患者、有ARDS风险的患者和ARDS患者(如果入院时可诊断为ARDS)。次要结局包括肺部并发症的发生和全因ICU死亡率。

伦理与传播

PRoVENT-iMIC将是第一项前瞻性评估亚洲ICU中有创通气患者的通气实践、结局和流行病学的国际研究。这项大型研究的结果将通过会议报告和在国际同行评审期刊上发表进行传播,在设计资源有限的ICU中有创通气试验时具有至关重要的意义。可根据要求并经PRoVENT-iMIC指导委员会同意,通过国家或国际匿名数据集获取源数据。

试验注册号

NCT03188770;预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9eb0/5931304/05fc3627d04d/bmjopen-2017-020841f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9eb0/5931304/aaa3887762a3/bmjopen-2017-020841f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9eb0/5931304/05fc3627d04d/bmjopen-2017-020841f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9eb0/5931304/aaa3887762a3/bmjopen-2017-020841f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9eb0/5931304/05fc3627d04d/bmjopen-2017-020841f02.jpg

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