ECCO2R as an Adjunct to NIV in AECOPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Device: NIVDevice: ECCO2R
- Registration Number
- NCT02086084
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Brief Summary
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 Our own unpublished series demonstrates the same physiological changes.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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NIV NIV Standard application of NIV in hypercapnic respiratory failure as per usual standard of care ECCO2R NIV Addition of ECCO2R to NIV in AECOPD ECCO2R ECCO2R Addition of ECCO2R to NIV in AECOPD
- Primary Outcome Measures
Name Time Method Time to cessation NIV 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.
- Secondary Outcome Measures
Name Time Method Time to cessation ECCO2R participants will be followed for the duration of ICU stay, an expected average of 4 days Defined as from the commencement of ECCO2R to 6 hours following cessation of CO2 removal
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 This is a composite endpoint to assess the ability to complete the required elements of the study from screening to commencement of ECCO2R in a clinically relevant timeframe
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 composite outcome of cannulation related complications
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 total caloric intake during interventional period
Mobilisation participants will be followed for the duration of ICU stay, an expected average of 4 days mobilisation from bed during the study period
thrombotic complications participants will be followed for the duration of ICU stay, an expected average of 4 days measurement of thrombotic complications in the patient related to the device
Trial Locations
- Locations (1)
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom