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Transplantation, Heart-LungCLADNCT02863835

Evaluation of Electrical Impedance Tomography for the Diagnosis of Chronic Rejection in Lung Transplants Recipients

A study testing EIT and Salbutamol nebulisation and with CPAP in people with Transplantation, Heart-Lung and Chronic Lung Allograft Dysfunction, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Electrical impedance tomography (EIT) is non-invasive and provides functional imaging of the lung and it could be a useful tool to diagnose chronic lung allograft dysfunction (CLAD) and specially Bronchiolitis Obliterans Syndrome (BOS). Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
EIT and Salbutamol nebulisation and with CPAP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2016to Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Bilateral lung transplant recipient
  • Time from lung transplantation > 6 months
  • A chest CT scan (HRCT) performed as part of their standard care in the last 3 months
  • A bronchoscopy with BAL and Biopsies performed as part of their standard care in the last 3 months
  • For group with CLAD: a drop in lung function assessed on FEV1 or FVC
  • For group without CLAD: an unchanged lung function

Who cannot join

  • Pregnancy
  • Body mass index > 40kg/m2
  • Significant physical or psychiatric comorbidity that would prevent compliance with trial protocol
  • Allergy to salbutamol
  • Patient with intra-bronchial or intra-tracheal metallic stent
  • Evidence of acute infection or acute cellular rejection.
  • In addition 10 healthy volunteers will be recruited

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Guys and St Thomas NHS Foundation

    London, SE1 7EH

Other trials in United Kingdom

About this study

Electrical impedance tomography (EIT) is non-invasive and provides functional imaging of the lung and it could be a useful tool to diagnose chronic lung allograft dysfunction (CLAD) and specially Bronchiolitis Obliterans Syndrome (BOS). Hence, for this study, the investigators aim to show that EIT would provide an accurate diagnostic CLAD with an ability to to distinguish BOS from Restrictive Allograft Syndrome (RAS) and to stage BOS accurately when compared to FEV1 the current gold standard. The investigators are also aiming to provide physiological data in lung transplant recipients with chronic rejection.

Read the detailed description

Lung transplantation is the only treatment option available for patients affected by end-stage lung diseases such as chronic obstructive pulmonary disease (COPD), cystic fibrosis or idiopathic pulmonary fibrosis, not responding to maximal medical therapy. Despite the advance in the surgical techniques, immunosuppression treatment and prevention of acute cellular rejection episodes as well as opportunistic infections, the long terms outcomes following lung transplant remain unsatisfactory. Chronic lung allograft dysfunction (CLAD) is the first cause of long term mortality in lung transplant recipients responsible of 5 years mortality post-surgery of 50%. CLAD can lead to chronic respiratory failure and can presents in two different phenotypes: Restrictive forms of CLAD were all lung volumes are decreased (commonly called RAS, Restrictive Allograft Syndrome) that has been recently associated with antibodies mediated rejection. A more common form of obstructive CLAD has been identified as the well-known and defined Bronchiolitis Obliterans Syndrome (BOS). In patients with BOS, the progressive obliteration and a narrowing of the distal airways result in breathlessness, airflow obstruction and air trapping.

Currently, Forced Expiratory Volume at 1 second (FEV1) measurement is the gold standard to assess BOS severity. This test is non invasive and easily performed at bedside. Thus, it only gives a broad idea of the regional consequences of BOS as may be influenced by large airway obstructions. Chest computed tomography (CT) gives more detailed imaging of the regional consequences of BOS but is time-consuming and expose patients to radiations. Others imaging techniques such as ventilation/perfusion scintigraphy have been studied but cannot be performed at bedside.

As to date there is no curative treatment for BOS, preventive treatments such as long term azithromycin, bronchodilators, inhaled steroids or plasmapheresis have to be started at early stage of the disease to improve outcomes for the recipients Electrical impedance tomography (EIT) is a new technology that involves wearing a belt of sensors around the chest that provides information on how well the lungs are being filled with air by the ventilator. It allows the assessment of these differences, which previously required the use of invasive equipment to obtain. Information is gained by repeatedly injecting small alternating electric currents (usually 5 mA) at high frequency of 50 - 80 kHz through a system of skin electrodes (usually 16) applied circumferentially around the thorax in a single plane between the 4th and 6th intercostal space. While an adjacent pair of electrodes 'injects' the current ('adjacent drive configuration'), all the remaining adjacent passive electrode pairs measure the differences in electric potential. A resistivity (impedance) image is reconstructed from this data by a mathematical algorithm using a two dimensional model and a simplified shape to represent the thoracic cross-section.

The resulting image possesses a high temporal and functional resolution making it possible to monitor dynamic physiological phenomena (e.g. delay in regional inflation or recruitment) on a breath by breath basis. It is important to realize that the EIT images are based on image reconstruction techniques that require at least one measurement on a well-defined reference state. All quantitative data are related to this reference and can only indirectly quantify (relative) changes in local lung impedance (but not absolute).

EIT can be used in mechanically ventilated patients to assess recruitment and to optimise ventilator settings to reduce risk of iatrogenic ventilator associated lung injury. To date, EIT has never been used in lung transplant recipients.

Being tested
EIT, Salbutamol nebulisation and with CPAP
Medical subject headings
Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EITOther

    All participants will have continuous monitoring of EIT whilst self venting

  • Salbutamol nebulisation and with CPAPOther

    All participants will have continuous monitoring - salbutamol nebulisation will be given during 15 minutes using 5mg of salbutamol. Assessments on CPAP will be performed at 3 different level of pressure during this time.

Study groups in NCT02863835
Study groupRoleWhat they receive
Intervention 1ExperimentalA 1:1 randomisation will be performed to decide the order of the administration of salbutamol and CPAP. All participants will receive both interventions in a cross-over fashion. Salbutamol nebulisation will be given during 15 minutes using 5mg of salbutamol. Assessments on CPAP will be performed at 3 different level of pressure. Each participant will then have continuous assessment of the following whilst self venting: * Spirometry - FEV1, FVC, MVV * Muscle strength measurements: MIP, MEP, SNIP * Borg scale, mMRC, Visual Analogue Scale for breathlessness * Electrical impedance tomography * EMGpara * Transcutaneous measurement of CO2 and 02 level * End-tidal CO2 monitoring * Pneumotachography
Receives: Other: EIT; Other: Salbutamol nebulisation and with CPAP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of chronic lung allograft dysfunction in lung transplant recipients identified with EIT

    Using EIT to diagnose chronic lung allograft dysfunction in lung transplant recipients

    Measured: 1 day

  2. Restrictive and obstructive phenotypes in recipients of lung transplants.

    Using EIT to distinguish between restrictive and obstructive different phenotypes in recipients of lung transplants

    Measured: 1 day

Secondary outcomes (5)
  1. Change in EIT results following administration of salbutamol and CPAP

    Following administration of salbutamol whilst using CPAP taking EITresults to determine if there is a change in the lungs

    Measured: 1 day

  2. Correlation EIT results and chest-CT results

    Comparing Lung measurements taken during the EIT test with the CT results of the participants to ascertain if there is any correlation

    Measured: 1 day

  3. Neural respiratory drive (EMGpara) of lung transplant recipients

    Comparing lung measurements taken during the EIT test with those taken during neural respiratory drive during the intervention

    Measured: 1 day

  4. Correlation between EIT and neural respiratory drive results with breathlessness

    Comparing lung measurements taken during the EIT test with the Neural respiratory drive results taken and the participants breathlessness

    Measured: 1 day

  5. Correlation of EIT results found in obstructive and restrictive allograft syndrome

    Comparing the obstructive allograft syndrome EIT results to the restrictive allograft syndrome results.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02863835
Sponsor's protocol ID
16/LO/0198
Acronym
CLAD
Status last verified
May 2018
First submitted
4 May 2016
Last updated
29 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing EIT and Salbutamol nebulisation and with CPAP in people with Transplantation, Heart-Lung and Chronic Lung Allograft Dysfunction, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of chronic lung allograft dysfunction in lung transplant recipients identified with EIT (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2018.

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