Vibration Response Imaging (VRI) in Lung Transplant Recipients
Condition: Lung Transplantation
Study type: Observational

Summary: 
      This study is a prospective, multi-center study. 50 lung transplant recipients will be
      enrolled in the study. Subjects will be selected from lung transplant recipients, who have
      undergone single or double lung transplantation during the last six months These patients
      will undergo a baseline VRI recording prior to the interventional procedure and a follow-up
      VRI at 1 hour after the interventional procedure. Furthermore, the patients will be recorded
      at the designated follow-up periods of 1, 3 and 6-month (+ 7 days) post-baseline visit, as
      well as before and 1 hour after any recurrent interventional procedure
    

Detailed description: 
      -  Study participants will be patients who have undergone lung transplantation during the
           last 6 months and are in a stable clinical position at the time of enrollment.

        -  Patients who meet the study inclusion and exclusion criteria will be enrolled in the
           study.

        -  The enrolled patients will be recorded with the VRI at each occurrence in which the
           standard procedures are performed:

             -  Baseline after study enrollment (VRI Recording 1 + standard evaluations).

             -  At each follow-up visit [1, 3, 6 months after baseline visit] during the 6 month
                follow-up period of the study (VRI Recordings + standard evaluations (if
                possible)).

             -  In the event of bronchoscopic intervention, then before the interventional
                procedure (VRI Recording 1 + standard evaluations) and before any recurrent
                interventional procedures (VRI Recordings + standard evaluations) during the course
                of the study (6-month follow-up period).

             -  1 hour after all bronchoscopic interventional procedures.

             -  In the event of an unanticipated visit, then a VRI recording will be performed (VRI
                Recordings + standard evaluations).

        -  All subjects will be recorded according to a standard procedure; moreover, it is
           essential that for each subject repeatable recordings will be performed in the same
           manner (i.e. breathing manner and matrix placement). Each VRI recording session will
           take ~15 minutes [the actual recording is ~2 minutes for placement and
           breathing/recording].

        -  Standard evaluation procedures may include any of the following:

             -  Lung function tests (this test is required at all visits)

             -  Physical examination

             -  Bronchoscopy (e.g. transbronchial biopsy)

             -  CT-imaging

             -  Chest x-ray

             -  V/Q Scan (Baseline visit for single lung transplantation)

             -  Blood gases (this test is required at all visits)

             -  Blood tests
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        50 lung transplant recipients will be enrolled in the study. Subjects will be selected from
        lung transplant recipients, who have undergone single or double lung transplantation during
        the last six months
      
Keywords: Lung Transplantation; Infections; Graft Rejection