ECCO2R as an Adjunct to NIV in AECOPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Extra-corporeal CO2 Removal as an Adjunct to Non-Invasive Ventilation in Acute Severe Exacerbations of COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086084
• Other study ID #: ECCO2R in AECOPD
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2021
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Our own unpublished series demonstrates the same physiological changes.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• NIV
Standard care
• ECCO2R
Application of ECCO2R in addition to NIV

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	Alung Technologies

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to cessation NIV	Time to cessation of NIV is defined as from NIV commencement to 6 hours without NIV.	participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	Mortality		at 90 days
Secondary	Time to event analysis	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	initial phase of study, an expected average of 3 hours
Secondary	Health-related quality of life (HRQoL)		90 days
Secondary	Cannulation-related outcomes	composite outcome of cannulation related complications	participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	haemolysis related to the intervention		participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	work of breathing		participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	Time to cessation ECCO2R	Defined as from the commencement of ECCO2R to 6 hours following cessation of CO2 removal	participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	Time to normalisation of pH		participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	Hospital Length of stay		participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary	Intubation rate		participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	Incidence of tracheostomy		participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	length of ICU stay		participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	Tolerance of therapy		participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	subjective dyspnoea		participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	nutrition	total caloric intake during interventional period	participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	Mobilisation	mobilisation from bed during the study period	participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	thrombotic complications	measurement of thrombotic complications in the patient related to the device	participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	respiratory mechanics		participants will be followed for the duration of ICU stay, an expected average of 4 days