Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure
NCT ID: NCT00523094
Last Updated: 2009-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
75 participants
OBSERVATIONAL
2007-09-30
2008-07-31
Brief Summary
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The secondary objective is to assess the correlation of the predicted post-operative lung function with the observed post-operative lung function (forced expiratory volume in 1 second \[FEV1\] and diffusing capacity of the lung for carbon monoxide \[DLCO\]) in patients who underwent surgical resection.
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Detailed Description
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Moreover, VRI may provide a safe, quick and simple method to measure "split function" in lung cancer patients who are candidates for lung surgery. Thus eliminating the safety and complexity issue related with the current ventilation perfusion "split function" methods.
In addition the VRI may aid in achieving the goal of developing strategies to reduce risk and maximize the number of patients that can benefit from surgical therapy.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Male or female in the age range of 18-80 years;
3. Patients who were referred to perform perfusion scan for pre lung surgery evaluation such as LVRS, thoracotomy, bullectomy and lobectomy.
4. Body mass index (BMI) \> 21.
Exclusion Criteria
2. Spine deformation (including scoliosis);
3. Hirsutism;
4. Potentially contagious skin lesion on the back;
5. Skin lesion that would interfere with sensor placement; (Keloids)
6. Cardiac pacemaker or implantable defibrillator;
18 Years
80 Years
ALL
No
Sponsors
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Deep Breeze
INDUSTRY
Responsible Party
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Deep Breeze
Principal Investigators
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Atul C. Mehta, M.D
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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References
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Benditt JO. Surgical therapies for chronic obstructive pulmonary disease. Respir Care. 2004 Jan;49(1):53-61; discussion 61-3.
Gurney JW. Pathophysiology of obstructive airways disease. Radiol Clin North Am. 1998 Jan;36(1):15-27. doi: 10.1016/s0033-8389(05)70005-1.
Salzman SH. Can CT measurement of emphysema severity aid patient selection for lung volume reduction surgery? Chest. 2000 Nov;118(5):1231-2. doi: 10.1378/chest.118.5.1231. No abstract available.
Corris PA, Ellis DA, Hawkins T, Gibson GJ. Use of radionuclide scanning in the preoperative estimation of pulmonary function after pneumonectomy. Thorax. 1987 Apr;42(4):285-91. doi: 10.1136/thx.42.4.285.
Arcasoy SM, Kotloff RM. Lung transplantation. N Engl J Med. 1999 Apr 8;340(14):1081-91. doi: 10.1056/NEJM199904083401406. No abstract available.
Hardoff R, Steinmetz AP, Krausz Y, Bar-Sever Z, Liani M, Kramer MR. The prognostic value of perfusion lung scintigraphy in patients who underwent single-lung transplantation for emphysema and pulmonary fibrosis. J Nucl Med. 2000 Nov;41(11):1771-6.
Cooper JD, Billingham M, Egan T, Hertz MI, Higenbottam T, Lynch J, Mauer J, Paradis I, Patterson GA, Smith C, et al. A working formulation for the standardization of nomenclature and for clinical staging of chronic dysfunction in lung allografts. International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 1993 Sep-Oct;12(5):713-6.
Kristersson S, Lindell SE, Svanberg L. Prediction of pulmonary function loss due to pneumonectomy using 133 Xe-radiospirometry. Chest. 1972 Dec;62(6):694-8. doi: 10.1378/chest.62.6.694. No abstract available.
Olsen GN, Block AJ, Tobias JA. Prediction of postpneumonectomy pulmonary function using quantitative macroaggregate lung scanning. Chest. 1974 Jul;66(1):13-6. doi: 10.1378/chest.66.1.13. No abstract available.
Ali MK, Mountain CF, Ewer MS, Johnston D, Haynie TP. Predicting loss of pulmonary function after pulmonary resection for bronchogenic carcinoma. Chest. 1980 Mar;77(3):337-42. doi: 10.1378/chest.77.3.337.
Ali MK, Ewer MS, Atallah MR, Mountain CF, Dixon CL, Johnston DA, Haynie TP. Regional and overall pulmonary function changes in lung cancer. Correlations with tumor stage, extent of pulmonary resection, and patient survival. J Thorac Cardiovasc Surg. 1983 Jul;86(1):1-8.
Kearney DJ, Lee TH, Reilly JJ, DeCamp MM, Sugarbaker DJ. Assessment of operative risk in patients undergoing lung resection. Importance of predicted pulmonary function. Chest. 1994 Mar;105(3):753-9. doi: 10.1378/chest.105.3.753.
Markos J, Mullan BP, Hillman DR, Musk AW, Antico VF, Lovegrove FT, Carter MJ, Finucane KE. Preoperative assessment as a predictor of mortality and morbidity after lung resection. Am Rev Respir Dis. 1989 Apr;139(4):902-10. doi: 10.1164/ajrccm/139.4.902.
Other Identifiers
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DB032
Identifier Type: -
Identifier Source: org_study_id
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