ECCO2R as an Adjunct to NIV in AECOPD
Study Details
Study Description
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 Our own unpublished series demonstrates the same physiological changes.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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: NIV Standard application of NIV in hypercapnic respiratory failure as per usual standard of care |
Device: NIV
Standard care
|
| Experimental: ECCO2R Addition of ECCO2R to NIV in AECOPD |
Device: NIV
Standard care
Device: ECCO2R
Application of ECCO2R in addition to NIV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- Mortality [at 90 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]
- 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
- haemolysis related to the intervention [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]
- 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
- Time to normalisation of pH [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]
- 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]
- Tolerance of therapy [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]
- 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
- respiratory mechanics [participants will be followed for the duration of ICU stay, an expected average of 4 days]
Eligibility Criteria
Criteria
Inclusion criteria
-
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
Exclusion Criteria
-
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
-
Vomiting
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guy's and St Thomas' NHS Foundation Trust | London | United Kingdom | SE1 7EH |
Sponsors and Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Alung Technologies
Investigators
- Principal Investigator: Nicholas Barrett, FCICM, Guy's and St Thomas' NHS Foundation Trust
- Principal Investigator: Luigi Camporota, PhD, Guy's and St Thomas' NHS Foundation Trust
- Principal Investigator: Nicholas Hart, PhD, Guy's and St Thomas' NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ECCO2R in AECOPD