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

NCT02863835 | Completed

• 1 other identifier: 16/LO/0198
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Transplantation, Heart-Lung; Chronic Lung Allograft Dysfunction; Bronchiolitis Obliterans Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

  1 day

• Restrictive and obstructive phenotypes in recipients of lung transplants.

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

  1 day

Secondary Outcomes (5)

• Change in EIT results following administration of salbutamol and CPAP

  1 day

• Correlation EIT results and chest-CT results

  1 day

• Neural respiratory drive (EMGpara) of lung transplant recipients

  1 day

• Correlation between EIT and neural respiratory drive results with breathlessness

  1 day

• Correlation of EIT results found in obstructive and restrictive allograft syndrome

  1 day

Study Arms (1)

Intervention 1

EXPERIMENTAL

A 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

Other: EIT; Other: Salbutamol nebulisation and with CPAP

Interventions

EIT OTHER

All participants will have continuous monitoring of EIT whilst self venting

Intervention 1

Salbutamol nebulisation and with CPAP OTHER

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.

Intervention 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• ADIR Association: collaborator

Study Sites (1)

Guys and St Thomas NHS Foundation

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Nick Hart

  Guy's and St Thomas' NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: August 11, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)