Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ECCO2R as an Adjunct to NIV in AECOPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02086084
Recruitment Status : Recruiting
First Posted : March 13, 2014
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
Alung Technologies
Information provided by (Responsible Party):
Nicholas Barrett, 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 Our own unpublished series demonstrates the same physiological changes.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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: NIV Device: ECCO2R Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Extra-corporeal CO2 Removal as an Adjunct to Non-Invasive Ventilation in Acute Severe Exacerbations of COPD
Actual Study Start Date : December 1, 2015
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : December 2021

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 Name: Haemolung




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086084


Contacts
Layout table for location contacts
Contact: Nicholas Barrett, FCICM +442071887188 ext 83038 nicholas.barrett@gstt.nhs.uk

Locations
Layout table for location information
United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Nicholas Barrett, FCICM       nicholas.barrett@gstt.nhs.uk   
Principal Investigator: Nicholas Barrett, FCICM         
Principal Investigator: Nicholas Hart, PhD         
Principal Investigator: Luigi Camporota, PhD         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Alung Technologies
Investigators
Layout table for investigator information
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nicholas Barrett, Consultant in Critical Care, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02086084     History of Changes
Other Study ID Numbers: ECCO2R in AECOPD
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Keywords provided by Nicholas Barrett, Guy's and St Thomas' NHS Foundation Trust:
Acute Exacerbation Chronic Obstructive Pulmonary Disease
AECOPD
Non invasive ventilation
NIV
Extracorporeal carbon dioxide removal
ECCO2R
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases