ECCO2R as an Adjunct to NIV in AECOPD

NCT02086084 | Completed

• 1 other identifier: ECCO2R in AECOPD
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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 Our own unpublished series demonstrates the same physiological changes.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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Acute Exacerbation Chronic Obstructive Pulmonary Disease; AECOPD; Non invasive ventilation; NIV; Extracorporeal carbon dioxide removal; ECCO2R

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Mortality

  at 90 days

• Time to event analysis

  initial phase of study, an expected average of 3 hours

• 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

• haemolysis related to the intervention

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

Study Arms (2)

NIV

ACTIVE COMPARATOR

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

Device: NIV

ECCO2R

EXPERIMENTAL

Addition of ECCO2R to NIV in AECOPD

Device: NIV; Device: ECCO2R

Interventions

NIV DEVICE

Standard care

ECCO2R; NIV

ECCO2R DEVICE

Application of ECCO2R in addition to NIV

Also known as: Haemolung

ECCO2R

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Alung Technologies: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (4)

• Barrett NA, Murgolo F, Grasso S, Kostakou E, Hart N, Murphy P, Douiri A, Camporota L. Physiological Assessment of ECCO2R on the Work of Breathing in Exacerbations of COPD. COPD. 2024 Dec;21(1):2436169. doi: 10.1080/15412555.2024.2436169. Epub 2024 Dec 5.

  PMID: 39639560 DERIVED

• Barrett NA, Hart N, Daly KJR, Marotti M, Kostakou E, Carlin C, Lua S, Singh S, Bentley A, Douiri A, Camporota L. A randomised controlled trial of non-invasive ventilation compared with extracorporeal carbon dioxide removal for acute hypercapnic exacerbations of chronic obstructive pulmonary disease. Ann Intensive Care. 2022 Apr 21;12(1):36. doi: 10.1186/s13613-022-01006-8.

  PMID: 35445986 DERIVED

• Barrett NA, Hart N, Camporota L. In vivo carbon dioxide clearance of a low-flow extracorporeal carbon dioxide removal circuit in patients with acute exacerbations of chronic obstructive pulmonary disease. Perfusion. 2020 Jul;35(5):436-441. doi: 10.1177/0267659119896531. Epub 2020 Jan 11.

  PMID: 31928313 DERIVED

• Barrett NA, Kostakou E, Hart N, Douiri A, Camporota L. Extracorporeal carbon dioxide removal for acute hypercapnic exacerbations of chronic obstructive pulmonary disease: study protocol for a randomised controlled trial. Trials. 2019 Jul 30;20(1):465. doi: 10.1186/s13063-019-3548-4.

  PMID: 31362776 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Critical Care

Study Record Dates

• First Submitted: March 9, 2014
• First Posted: March 13, 2014
• Study Start: December 1, 2015
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 11, 2021

Record last verified: 2021-08

Locations

GB (1)