|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02863835 |
|
Date of registration:
|
04/05/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Evaluation of Electrical Impedance Tomography for the Diagnosis of Chronic Rejection in Lung Transplants Recipients
CLAD |
|
Scientific title:
|
Evaluation of Electrical Impedance Tomography for the Diagnosis of Chronic Rejection in Lung Transplants Recipients |
|
Date of first enrolment:
|
April 2016 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02863835 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
Nick Hart |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Guys and St Thomas' NHS Foundation Trust |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Bronchiolitis Obliterans Syndrome
|
|
Transplantation, Heart-Lung
|
|
Chronic Lung Allograft Dysfunction
|
|
Intervention(s)
|
|
Other: EIT
|
|
Other: Salbutamol nebulisation and with CPAP
|
|
Primary Outcome(s)
|
|
Number of chronic lung allograft dysfunction in lung transplant recipients identified with EIT
[Time Frame: 1 day]
|
|
Restrictive and obstructive phenotypes in recipients of lung transplants.
[Time Frame: 1 day]
|
|
Secondary Outcome(s)
|
|
Change in EIT results following administration of salbutamol and CPAP
[Time Frame: 1 day]
|
|
Correlation between EIT and neural respiratory drive results with breathlessness
[Time Frame: 1 day]
|
|
Correlation EIT results and chest-CT results
[Time Frame: 1 day]
|
|
Neural respiratory drive (EMGpara) of lung transplant recipients
[Time Frame: 1 day]
|
|
Correlation of EIT results found in obstructive and restrictive allograft syndrome
[Time Frame: 1 day]
|
|
Secondary ID(s)
|
|
16/LO/0198
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|