Vibration Response Imaging (VRI) in Lung Transplant Recipients

Lung Transplantation Clinical Trial

Official title:

Vibration Response Imaging (VRI) in Lung Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744822
• Other study ID #: 4066
• Status: Completed
• Phase: N/A
• First received: August 28, 2008
• Last updated: August 28, 2008
• Start date: March 2006
• Est. completion date: March 2007

Study information

• Verified date: December 2005
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be entered into the study:

1. Able and willing to read, understand, and provide written Informed Consent

2. Male or Female in the age range of 18-65 years

3. Subject is a lung transplant recipient who underwent single or double lung transplantation within the last 6 months

4. BMI > 19

5. Height of >1.55 meters

6. Stable clinical condition at study baseline evaluation

Exclusion Criteria:

Any of the following will exclude the subject from study:

1. Intubated patients

2. Chest wall deformation

3. Spine deformation (including severe scoliosis)

4. Hirsutism

5. Potentially contagious skin lesion on the back

6. Skin lesion that would interfere with sensor placement

7. Cardiac pacemaker or implantable defibrillator

8. Patient is pregnant as confirmed with urine pregnancy test

9. Colonization of multi-resistant bacteria (MRSA) If the subject meets all of the inclusion criteria and none of the exclusion criteria, he/she is eligible to participate in the study.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Transplantation

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Deep Breeze

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months	No
Secondary	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].		6 months	No