This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This is a prospective, consecutive case, multicenter registry to establish benchmarks for safety and outcomes in patients undergoing interventional bronchoscopy procedures for airway obstruction. The purpose of this study is to more precisely quantify and describe complications, clinical outcomes, and quality of life (QOL) measures following interventional bronchoscopy procedures for treatment of malignant and benign central airway obstruction. Specifically, the investigators wish to more accurately measure complication rates (pneumothorax, bleeding, arrhythmia, stent migration rates, stent granulation rates, stent infection rates, pneumonia rates), restenosis rates, infection rates, patient assessed QOL, and survival. Patients eligible for the study are those 18 years and older with incurable malignant obstruction of the central airway including the trachea, left or right mainstem bronchus or bronchus intermedius with symptoms related to the obstruction including dyspnea or post-obstructive pneumonia. In addition, patients with benign conditions affecting patency of the airway will be considered for inclusion if the intervention required includes bronchoscopy with laser or electrocautery interventions or dilation and stenting. The goal of this registry will be to study advanced bronchoscopic interventions more systematically and rigorously, by applying validated tools for assessment of quality of life and to follow patients longitudinally so that more precise estimates of long-term impacts can be made. This will hopefully facilitate future research and development for new stent technologies and other bronchoscopic interventions. The interventional bronchoscopy procedures included are all FDA approved and are currently part of the standard of care. Follow-up bronchoscopies, blood tests, and PFT's, as well as routine office visits will be carried out according to the routine standard of care. The systematic measurement of QOL using the Saint George's Respiratory Questionnaire (SGRQ), BDI/TDI, and ATS score are not part of the routine standard of care. The measurement of QOL data, quantitative dyspnea assessment, and longitudinal outcome measures to determine QALY will be part of the GCRC. Patients in the registry would still be eligible for any other GCRC protocols, should they so choose.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000096-47
Application #
7718465
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2008-04-01
Project End
2009-03-31
Budget Start
2008-04-01
Budget End
2009-03-31
Support Year
47
Fiscal Year
2008
Total Cost
$2,018
Indirect Cost
Name
New York University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016
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