Assessment of breath volatile organic compounds in acute cardiorespiratory breathlessness: a protocol describing a prospective real-world observational study
Assessment of breath volatile organic compounds in acute cardiorespiratory breathlessness: a protocol describing a prospective real-world observational study
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DOI：
10.1136/bmjopen-2018-025486
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发表时间：
2019-06-01
期刊：
影响因子：
2.9
通讯作者：
Siddiqui, Salman
中科院分区：
文献类型：
--
作者：
Ibrahim, Wadah;Wilde, Michael;Siddiqui, Salman
简介在英国各地的住院病房中，经常会遇到出现急性未分化性呼吸困难的患者。现有的血液生物标记物在区分单器官病变患者方面具有临床实用价值，但在多因素表现方面的区分能力较差。对呼气中挥发性有机化合物(VOCs)的评估提供了开发疾病状态生物标志物的可能性，这些疾病状态支持急性心肺呼吸困难，因为它们接近心肺系统。到目前为止，还没有系统地评估VOC在急性心肺呼吸困难中的作用。这项拟议的研究将寻求使用线下和在线VOC技术来评估VOC在确定出现急性心肺呼吸困难的常见情况方面的预测价值。方法和分析一项对莱斯特郡三个急性收治病房进行的前瞻性真实世界观察研究。自行报告的急性呼吸困难，确诊为急性心力衰竭、社区获得性肺炎和哮喘急性加重或慢性阻塞性肺疾病的参与者将在入院后24小时内招募。此外，将对入院的患有严重哮喘的学龄儿童进行评估。所有参与者在入院时和出院后康复时都要进行呼气采样。包括质子转移反应质谱仪、气相色谱-离子迁移率质谱仪、常压化学电离-质谱仪在内的一系列在线技术和包括气相色谱-质谱仪和综合二维气相色谱-质谱仪在内的离线技术将被用于VOC的发现和复制。对于离线技术，将使用标准化的CE标志呼气采样设备(ReCIVA)。所有招募的参与者将使用现有的血液生物标记物进行表征，包括C反应蛋白、脑源性钠尿肽、肌钙蛋白-I和血嗜酸性粒细胞水平，并使用一系列标准化问卷、肺功能测试、痰细胞计数和其他与急性疾病有关的诊断测试进行进一步评估。伦理与传播国家研究伦理服务委员会东米德兰兹郡已批准该研究方案(REC编号：16/LO/1747)。综合研究审批系统(IRAS)198921。研究结果将在学术会议上发表，并发表在同行评议的科学期刊上。传播将通过与东米德兰兹郡学术健康科学网络的伙伴关系以及通过与所有英国资助的医学研究理事会和工程和物理科学研究理事会分子病理学节点的互动来促进。
Introduction Patients presenting with acute undifferentiated breathlessness are commonly encountered in admissions units across the UK. Existing blood biomarkers have clinical utility in distinguishing patients with single organ pathologies but have poor discriminatory power in multifactorial presentations. Evaluation of volatile organic compounds (VOCs) in exhaled breath offers the potential to develop biomarkers of disease states that underpin acute cardiorespiratory breathlessness, owing to their proximity to the cardiorespiratory system. To date, there has been no systematic evaluation of VOC in acute cardiorespiratory breathlessness. The proposed study will seek to use both offline and online VOC technologies to evaluate the predictive value of VOC in identifying common conditions that present with acute cardiorespiratory breathlessness.Methods and analysis A prospective real-world observational study carried out across three acute admissions units within Leicestershire. Participants with self-reported acute breathlessness, with a confirmed primary diagnosis of either acute heart failure, community-acquired pneumonia and acute exacerbation of asthma or chronic obstructive pulmonary disease will be recruited within 24 hours of admission. Additionally, school-age children admitted with severe asthma will be evaluated. All participants will undergo breath sampling on admission and on recovery following discharge. A range of online technologies including: proton transfer reaction mass spectrometry, gas chromatography ion mobility spectrometry, atmospheric pressure chemical ionisation-mass spectrometry and offline technologies including gas chromatography mass spectroscopy and comprehensive two-dimensional gas chromatography-mass spectrometry will be used for VOC discovery and replication. For offline technologies, a standardised CE-marked breath sampling device (ReCIVA) will be used. All recruited participants will be characterised using existing blood biomarkers including C reactive protein, brain-derived natriuretic peptide, troponin-I and blood eosinophil levels and further evaluated using a range of standardised questionnaires, lung function testing, sputum cell counts and other diagnostic tests pertinent to acute disease.Ethics and dissemination The National Research Ethics Service Committee East Midlands has approved the study protocol (REC number: 16/LO/1747). Integrated Research Approval System (IRAS) 198921. Findings will be presented at academic conferences and published in peer-reviewed scientific journals. Dissemination will be facilitated via a partnership with the East Midlands Academic Health Sciences Network and via interaction with all UK-funded Medical Research Council and Engineering and Physical Sciences Research Council molecular pathology nodes.