Vibration Response Imaging (VRI) in Lung Transplant Recipients

NCT00744822 | Completed DMC

• 1 other identifier: 4066
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lung Transplantation

Keywords

Lung Transplantation; Infections; Graft Rejection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Able and willing to read, understand, and provide written Informed Consent
• Male or Female in the age range of 18-65 years
• Subject is a lung transplant recipient who underwent single or double lung transplantation within the last 6 months
• BMI \> 19
• Height of \>1.55 meters
• Stable clinical condition at study baseline evaluation

You may not qualify if:

• Any of the following will exclude the subject from study:
• Intubated patients
• Chest wall deformation
• Spine deformation (including severe scoliosis)
• Hirsutism
• Potentially contagious skin lesion on the back
• Skin lesion that would interfere with sensor placement
• Cardiac pacemaker or implantable defibrillator
• Patient is pregnant as confirmed with urine pregnancy test

Sponsors & Collaborators

• Hannover Medical School: lead
• Deep Breeze: collaborator

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Infections

Study Officials

• Tobias Welte, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: September 1, 2008
• Study Start: March 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: September 1, 2008

Record last verified: 2005-12

Locations

DE (1)