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 Overview

• Status: Completed
• Conditions: Lung Transplantation

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

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Hannover Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: Deep Breeze
• Investigators: Principal Investigator: Tobias Welte, MD, Hannover Medical School

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: August 28, 2008
• First Submitted That Met QC Criteria: August 28, 2008
• First Posted (Estimate): September 1, 2008

Study Record Updates

• Last Update Posted (Estimate): September 1, 2008
• Last Update Submitted That Met QC Criteria: August 28, 2008
• Last Verified: December 1, 2005

More Information

Terms related to this study

• Keywords: Infections; Graft Rejection; Lung Transplantation
• Other Study ID Numbers: 4066