ECCO2R as an Adjunct to NIV in AECOPD

Guy's and St Thomas' NHS Foundation Trust

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: ECCO2R; Device: NIV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02086084

ECCO2R in AECOPD

Details and patient eligibility

About

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 Our own unpublished series demonstrates the same physiological changes.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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

NIV

Active Comparator group

Description:

Standard application of NIV in hypercapnic respiratory failure as per usual standard of care

Treatment:

Device: NIV

ECCO2R

Experimental group

Description:

Addition of ECCO2R to NIV in AECOPD

Treatment:

Device: NIV

Device: ECCO2R