Vibration Response Imaging (VRI) in Lung Transplant Recipients
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
|Study Design:||Time Perspective: Prospective|
|Official Title:||Vibration Response Imaging (VRI) in Lung Transplant Recipients|
- The primary study objective is to evaluate the ability of VRI lung images in single lung or double lung transplant recipients to assist the physician in detecting risk factors associated with lung transplantation during the six-month follow-up period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- The secondary objective is to compare evaluations of the lung VRI images with the results of other evaluation techniques [i.e. PFT, chest X-ray]. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||March 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
- 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)
- Chest x-ray
- V/Q Scan (Baseline visit for single lung transplantation)
- Blood gases (this test is required at all visits)
- Blood tests