Department of Respiratory Sciences, College of Life Sciences, University of Leicester, Leicester, UK.
University Hospitals of Leicester NHS Trust, Leicester, UK.
BMJ Open. 2019 Mar 8;9(3):e025486. doi: 10.1136/bmjopen-2018-025486.
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.
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.
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.
NCT03672994.
在英国各地的入院病房中，经常会遇到出现急性不明原因呼吸困难的患者。现有的血液生物标志物在鉴别单一器官疾病方面具有临床实用性，但在多因素表现方面的鉴别能力较差。评估呼气中的挥发性有机化合物（VOC）有可能为急性心肺呼吸急促的疾病状态开发生物标志物，因为它们靠近心肺呼吸系统。迄今为止，尚未对急性心肺呼吸急促的 VOC 进行系统评估。拟议的研究将尝试使用离线和在线 VOC 技术来评估 VOC 识别伴有急性心肺呼吸急促的常见病症的预测价值。
这是一项在莱斯特郡的三个急性入院病房进行的前瞻性真实世界观察性研究。在入院后 24 小时内，将招募自我报告有急性呼吸困难且经证实的主要诊断为急性心力衰竭、社区获得性肺炎和哮喘急性加重或慢性阻塞性肺疾病的患者，此外，还将评估因严重哮喘入院的学龄儿童。所有参与者将在入院时和出院后恢复时进行呼吸采样。将使用一系列在线技术，包括质子转移反应质谱、气相离子迁移谱、大气压化学电离质谱和离线技术，包括气相色谱质谱和全面二维气相色谱质谱，用于 VOC 发现和复制。对于离线技术，将使用经过标准化认证的呼气采样设备（ReCIVA）。所有招募的参与者将使用现有的血液生物标志物进行特征描述，包括 C 反应蛋白、脑利钠肽、肌钙蛋白 I 和血液嗜酸性粒细胞水平，并使用一系列标准问卷、肺功能测试、痰细胞计数和其他与急性疾病相关的诊断测试进一步评估。
东米德兰国家研究伦理服务委员会已批准研究方案（REC 编号：16/LO/1747）。综合研究批准系统（IRAS）198921。研究结果将在学术会议上公布，并发表在同行评议的科学期刊上。将通过与东米德兰学术健康科学网络的合作以及与所有英国资助的医学研究委员会和工程与物理科学研究理事会分子病理学节点的互动来促进传播。
NCT03672994。
