Vibration Response Imaging (VRI) in Lung Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Deep Breeze
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00744822
First received: August 28, 2008
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

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


Condition
Lung Transplantation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Vibration Response Imaging (VRI) in Lung Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: March 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744822

Locations
Germany
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Deep Breeze
Investigators
Principal Investigator: Tobias Welte, MD Hannover Medical School
  More Information

No publications provided

Responsible Party: Merav Gat, Director of Clinical Affairs, Deep Breeze Ltd.
ClinicalTrials.gov Identifier: NCT00744822     History of Changes
Other Study ID Numbers: 4066
Study First Received: August 28, 2008
Last Updated: August 28, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by Hannover Medical School:
Lung Transplantation
Infections
Graft Rejection

ClinicalTrials.gov processed this record on August 26, 2014