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Completed

NCT Number: NCT02086084

ECCO2R as an Adjunct to NIV in AECOPD

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 Our own unpublished series demonstrates the same physiological changes.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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIV

Device

Standard care

ECCO2R

Device

Application of ECCO2R in addition to NIV

Other names: Haemolung

Primary outcomes

  1. Time to cessation NIV

    Time frame: 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 outcomes

  1. Mortality

    Time frame: at 90 days

  2. Time to event analysis

    Time frame: 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

  3. Health-related quality of life (HRQoL)

    Time frame: 90 days

  4. Cannulation-related outcomes

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days

    composite outcome of cannulation related complications

  5. haemolysis related to the intervention

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days

  6. work of breathing

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days

  7. Time to cessation ECCO2R

    Time frame: 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

  8. Time to normalisation of pH

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days

  9. Hospital Length of stay

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days

  10. Intubation rate

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days

  11. Incidence of tracheostomy

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days

  12. length of ICU stay

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days

  13. Tolerance of therapy

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days

  14. subjective dyspnoea

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days

  15. nutrition

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days

    total caloric intake during interventional period

  16. Mobilisation

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days

    mobilisation from bed during the study period

  17. thrombotic complications

    Time frame: 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

  18. respiratory mechanics

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • Alung Technologies

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2014
Registry last updated
Aug 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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