Barrett Nicholas A, Kostakou Eirini, Hart Nicholas, Douiri Abdel, Camporota Luigi
Department of Critical Care, Guy's and St Thomas' NHS Foundation Trust, Westminster Bridge Rd, London, SE1 7EH, UK.
Centre for Human & Applied Physiological Sciences (CHAPS), School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.
Trials. 2019 Jul 30;20(1):465. doi: 10.1186/s13063-019-3548-4.
Chronic obstructive pulmonary disease (COPD) is a common cause of chronic respiratory failure and its course is punctuated by a series of acute exacerbations which commonly lead to hospital admission. Exacerbations are managed through the application of non-invasive ventilation and, when this fails, tracheal intubation and mechanical ventilation. The need for mechanical ventilation significantly increases the risk of death. An alternative therapy, extracorporeal carbon dioxide removal (ECCOR), has been shown to be efficacious in removing carbon dioxide from the blood; however, its impact on respiratory physiology and patient outcomes has not been explored.
METHODS/DESIGN: A randomised controlled open label trial of patients (12 in each arm) with acute exacerbations of COPD at risk of failing conventional therapy (NIV) randomised to either remaining on NIV or having ECCOR added to NIV with a primary endpoint of time to cessation of NIV. The change in respiratory physiology following the application of ECCOR and/or NIV will be measured using electrical impedance tomography, oesophageal pressure and parasternal electromyography. Additional outcomes, including patient tolerance, outcomes, need for readmission, changes in blood gases and biochemistry and procedural complications, will be measured. Physiological changes will be compared within one patient over time and between the two groups. Healthcare costs in the UK system will also be compared between the two groups.
COPD is a common disease and exacerbations are a leading cause of hospital admission in the UK and worldwide, with a sizeable mortality. The management of patients with COPD consumes significant hospital and financial resources. This study seeks to understand the feasibility of a novel approach to the management of patients with acute exacerbations of COPD as well as to understand the underlying physiological changes to explain why the approach does or does not assist this patient cohort. Detailed respiratory physiology has not been previously undertaken using this technique and there are no other randomised controlled trials currently in the literature.
ClinicalTrials.gov, NCT02086084.
慢性阻塞性肺疾病（COPD）是慢性呼吸衰竭的常见病因，其病程中会出现一系列急性加重期，通常导致患者住院。急性加重期的治疗方法包括应用无创通气，若无创通气失败，则进行气管插管和机械通气。机械通气的需求会显著增加死亡风险。另一种治疗方法，体外二氧化碳清除（ECCOR），已被证明在从血液中清除二氧化碳方面有效；然而，其对呼吸生理和患者预后的影响尚未得到研究。
方法/设计：一项随机对照开放标签试验，将有常规治疗（无创通气）失败风险的COPD急性加重期患者（每组12例）随机分为继续接受无创通气或在无创通气基础上加用ECCOR两组，主要终点为无创通气停止时间。应用ECCOR和/或无创通气后呼吸生理的变化将通过电阻抗断层成像、食管压力和胸骨旁肌电图进行测量。还将测量其他结局，包括患者耐受性、预后、再入院需求、血气和生化指标的变化以及操作并发症。将在同一患者内随时间以及两组之间比较生理变化。还将比较两组在英国医疗系统中的医疗费用。
COPD是一种常见疾病，急性加重期是英国和全球住院的主要原因，死亡率很高。COPD患者的管理消耗了大量的医院和财政资源。本研究旨在了解一种治疗COPD急性加重期患者新方法的可行性，以及了解潜在的生理变化，以解释该方法为何有助于或无助于这一患者群体。此前尚未使用该技术进行详细的呼吸生理研究，目前文献中也没有其他随机对照试验。
ClinicalTrials.gov，NCT02086084。
