ECCO2R as an Adjunct to NIV in AECOPD

N/ACompletedNCT02086084

Guy's and St Thomas' NHS Foundation Trust21 enrolled

Overview

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 Our own unpublished series demonstrates the same physiological changes.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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time to cessation NIV

Time to cessation of NIV is defined as from NIV commencement to 6 hours without NIV.

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

Secondary Outcomes

Mortality

Time frame: at 90 days

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

Time frame: initial phase of study, an expected average of 3 hours

Health-related quality of life (HRQoL)

Time frame: 90 days

Cannulation-related outcomes

composite outcome of cannulation related complications

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

haemolysis related to the intervention

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

work of breathing

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

Time to cessation ECCO2R

Defined as from the commencement of ECCO2R to 6 hours following cessation of CO2 removal

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

Time to normalisation of pH

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

Hospital Length of stay

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

Intubation rate

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

Incidence of tracheostomy

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

length of ICU stay

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

Tolerance of therapy

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

subjective dyspnoea

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

nutrition

total caloric intake during interventional period

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

Mobilisation

mobilisation from bed during the study period

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

thrombotic complications

measurement of thrombotic complications in the patient related to the device

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

respiratory mechanics

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

ECCO2R as an Adjunct to NIV in AECOPD

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes