Extra-corporeal CO2 Removal as an Adjunct to Non-Invasive Ventilation in Acute Severe Exacerbations of COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Time to cessation NIV
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is one of the UKs commonest chronic diseases and is responsible for a significant number of acute hospital admissions. COPD is characterised by progressive destruction in the elastic tissue within the lung, causing respiratory failure. The clinical course of COPD is characterised by recurrent acute exacerbations (AECOPD), causing considerable morbidity and mortality. Patients with moderate to severe acute exacerbations present with increased work of breathing and hypercapnia. The standard for respiratory support in this setting is non-invasive ventilation (NIV), a management strategy underpinned by a considerable evidence base. However despite NIV, up to 30% of patients with AECOPD will 'fail' and require intubation and mechanical ventilation. The mortality rate for patients requiring NIV is approximately 4%, if conversion to mechanical ventilation occurs the mortality is 29%.
The last decade has seen an increasing interest in the provision of extracorporeal support for respiratory failure. The key element that has underpinned improving survival has been technological advancement. This has resulted in pumps causing less blood trauma and inflammatory response, better percutaneous cannulation techniques and coated circuits with reduced heparin requirements. Overall this has significantly reduced the complications associated with the provision of extracorporeal support. One variation of this technique (extra-corporeal CO2 removal ECCO2R) allows CO2 clearance from the blood. This approach has been the subject of a number of animal experiments and uncontrolled human case series demonstrating improved arterial CO2 and reduced work of breathing. Our own unpublished series demonstrates the same physiological changes. However to date the benefits of this approach have not been tested in a randomised controlled trial.
The hypothesis is that the addition of ECCO2R to NIV will shorten the duration of NIV and reduce likelihood of intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known COPD with an acute exacerbation. An acute exacerbation is defined as per the GOLD criteria as an increase in dyspnoea, cough and/or sputum over the patient's normal symptoms. A severe exacerbation is defined as one requiring hospital admission.
- •Patients with a persistent arterial pH<7.30 due primarily to hypercapnic respiratory failure after standard medical therapy and at least 1 hour of NIV.
- •Age over 18
排除标准
- •Haemodynamic instability after ensuring euvolaemia
- •Acute multiple organ failure requiring other organ supportive therapy, including indication for intubation and mechanical ventilation
- •Known allergy/intolerance of heparin including known heparin induced thrombosis and thrombocytopaenia
- •Acute uncontrolled haemorrhage
- •Intracerebral haemorrhage
- •Recent (<6 months) ischaemic cerebrovascular accident
- •Organ transplant recipient
- •Expected to die within 24 hours
- •Venous abnormality or body habitus precluding cannulation
- •Contraindication to NIV (as per British Thoracic Society recommendation)
- •Facial burns/trauma/recent facial or upper airway surgery
- •Fixed upper airway obstruction
- •Undrained pneumothorax
- •Recent upper gastrointestinal surgery
- •Inability to protect the airway
- •Life threatening hypoxaemia (PaO2/FiO2 <20kPa)
- •Bowel obstruction
- •Patient refusal
- •Pregnancy
- •Severe hepatic failure (ascites, hepatic encephalopathy or bilirubin >100umol/L)
- •Severe chronic cardiac failure (NYHA class III or IV)
- •Bleeding diathesis (INR>1.5, platelets <80,000) in the absence of anticoagulation therapy
研究组 & 干预措施
ECCO2R
Addition of ECCO2R to NIV in AECOPD
干预措施: NIV (Device)
ECCO2R
Addition of ECCO2R to NIV in AECOPD
干预措施: ECCO2R (Device)
NIV
Standard application of NIV in hypercapnic respiratory failure as per usual standard of care
干预措施: NIV (Device)
结局指标
主要结局
Time to cessation NIV
时间窗: participants will be followed for the duration of ICU stay, an expected average of 4 days
Time to cessation of NIV is defined as from NIV commencement to 6 hours without NIV.
次要结局
- Time to cessation ECCO2R(participants will be followed for the duration of ICU stay, an expected average of 4 days)
- haemolysis related to the intervention(participants will be followed for the duration of ICU stay, an expected average of 4 days)
- Time to normalisation of pH(participants will be followed for the duration of ICU stay, an expected average of 4 days)
- respiratory mechanics(participants will be followed for the duration of ICU stay, an expected average of 4 days)
- Time to event analysis(initial phase of study, an expected average of 3 hours)
- Health-related quality of life (HRQoL)(90 days)
- Intubation rate(participants will be followed for the duration of ICU stay, an expected average of 4 days)
- Incidence of tracheostomy(participants will be followed for the duration of ICU stay, an expected average of 4 days)
- length of ICU stay(participants will be followed for the duration of ICU stay, an expected average of 4 days)
- work of breathing(participants will be followed for the duration of ICU stay, an expected average of 4 days)
- Hospital Length of stay(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Mortality(at 90 days)
- Cannulation-related outcomes(participants will be followed for the duration of ICU stay, an expected average of 4 days)
- subjective dyspnoea(participants will be followed for the duration of ICU stay, an expected average of 4 days)
- Tolerance of therapy(participants will be followed for the duration of ICU stay, an expected average of 4 days)
- nutrition(participants will be followed for the duration of ICU stay, an expected average of 4 days)
- Mobilisation(participants will be followed for the duration of ICU stay, an expected average of 4 days)
- thrombotic complications(participants will be followed for the duration of ICU stay, an expected average of 4 days)
研究者
Nicholas Barrett
Consultant in Critical Care
Guy's and St Thomas' NHS Foundation Trust