Pulmonary Emphysema Clinical Trial
Official title:
Randomized Comparison of Thoracoscopic Lung Volume Reduction Surgery Performed by Resectional Surgical Technique Under General Anesthesia or by a Non-Resectional Technique in Awake Patients Under Sole Epidural Anesthesia
Lung volume reduction surgery is effective in improving pulmonary function and quality of life in selected patients with severe emphysema although the morbidity of this surgical procedure is still considerable. Morbidity is mainly addressed to general anesthesia-related adverse effects and surgical trauma deriving from lung resection. Having developed an awake nonresectional lung volume reduction surgery technique, which is performed under sole thoracic epidural anesthesia, we have hypothesized that it could offer satisfactory clinical results and reduced morbidity rate when compared with the conventional surgical procedure.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Severe smoking-related emphysema with upper-lobe predominance - Severe disability (MMRC dyspnea grade>=3) despite maximized medical therapy including respiratory rehabilitation - No clinically significant sputum production, bronchiectasis or asthma postbronchodilator forced expiratory volume in onee second (FEV1)<40% predicted - Residual volume (RV)>180% predicted at body plethysmography - Total Lung capacity>120% predicted - No instable angina or ventricular arrythmia - Peak systolic pulmonary artery pressure <50 mmHg at echocardiocolordoppler - Arterial carbon dioxide (PaCO2)<50 mmHg - Diffusion capacity of carbon monoxide (DLCO)> 20% predicted - Quit smoking since at least 4 months - ASA score<=3 - Body mass index >18 <29 - No comorbid condition that would significantly increase operative risk or negatively affect participation in a vigorous respiratory rehabilitation program - No neoplastic disease with life expectancy < 12 months - No previous pleurodesis or thoracotomy in the more affected hemithorax Exclusion Criteria: - Radiologic evidence of extensive pleural adhesions with pleural scarring and calcifications on site targeted for LVRS - Patients refusal or noncompliance to thoracic epidural anesthesia and awake surgery - Patients refusal or noncompliance to general surgery and one-lung ventilation - Unfavorable anatomy for thoracic epidural anesthesia - Previous surgery of the cervical or upper thoracic spine - Compromised coagulation (thromboplastin time<80%, prothrombin time>40 sec, platelet count<100/nL or bleeding disorder |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Tor Vergata University | Rome |
Lead Sponsor | Collaborator |
---|---|
University of Rome Tor Vergata |
Italy,
Mineo TC, Ambrogi V, Pompeo E, Bollero P, Mineo D, Nofroni I; Pulmonary Emphysema Research Group. Body weight and nutritional changes after reduction pneumoplasty for severe emphysema: a randomized study. J Thorac Cardiovasc Surg. 2002 Oct;124(4):660-7. — View Citation
Mineo TC, Ambrogi V, Pompeo E, Elia S, Mineo D, Bollero P, Nofroni I. Impact of lung volume reduction surgery versus rehabilitation on quality of life. Eur Respir J. 2004 Feb;23(2):275-80. — View Citation
Mineo TC, Pompeo E, Mineo D, Ambrogi V, Ciarapica D, Polito A. Resting energy expenditure and metabolic changes after lung volume reduction surgery for emphysema. Ann Thorac Surg. 2006 Oct;82(4):1205-11. — View Citation
Mineo TC, Pompeo E, Mineo D, Rogliani P, Leonardis C, Nofroni I. Results of unilateral lung volume reduction surgery in patients with distinct heterogeneity of emphysema between lungs. J Thorac Cardiovasc Surg. 2005 Jan;129(1):73-9. — View Citation
Mineo TC, Pompeo E, Mineo D, Tacconi F, Marino M, Sabato AF. Awake nonresectional lung volume reduction surgery. Ann Surg. 2006 Jan;243(1):131-6. — View Citation
Mineo TC, Pompeo E, Rogliani P, Dauri M, Turani F, Bollero P, Magliocchetti N. Effect of lung volume reduction surgery for severe emphysema on right ventricular function. Am J Respir Crit Care Med. 2002 Feb 15;165(4):489-94. — View Citation
Mineo TC, Pompeo E. Long-term results of tailored lung volume reduction surgery for severe emphysema. Clin Ter. 2007 Mar-Apr;158(2):127-33. — View Citation
Pompeo E, De Dominicis E, Ambrogi V, Mineo D, Elia S, Mineo TC. Quality of life after tailored combined surgery for stage I non-small-cell lung cancer and severe emphysema. Ann Thorac Surg. 2003 Dec;76(6):1821-7. — View Citation
Pompeo E, Marino M, Nofroni I, Matteucci G, Mineo TC. Reduction pneumoplasty versus respiratory rehabilitation in severe emphysema: a randomized study. Pulmonary Emphysema Research Group. Ann Thorac Surg. 2000 Sep;70(3):948-53; discussion 954. — View Citation
Pompeo E, Mineo TC. Two-year improvement in multidimensional body mass index, airflow obstruction, dyspnea, and exercise capacity index after nonresectional lung volume reduction surgery in awake patients. Ann Thorac Surg. 2007 Dec;84(6):1862-9; discussion 1862-9. — View Citation
Pompeo E, Mineo TC; Pulmonary Emphysema Research group. Long-term outcome of staged versus one-stage bilateral thoracoscopic reduction pneumoplasty. Eur J Cardiothorac Surg. 2002 Apr;21(4):627-33; discussion 633. — View Citation
Tacconi F, Pompeo E, Mineo TC. Late-onset occult pneumothorax after lung volume-reduction surgery. Ann Thorac Surg. 2005 Dec;80(6):2008-12. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mortality | 3 months | Yes | |
Primary | Hospital stay | 2 months | Yes | |
Primary | Forced expiratory volume in one second | 24 months | No | |
Primary | Residual volume | 24 months | No | |
Primary | Modified Medical research Council Dyspnea index | 24 months | No | |
Secondary | Arterial carbon dioxide tension (mmHg) | 2 days | Yes | |
Secondary | Arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) | 2 days | Yes | |
Secondary | Anesthesia satisfaction score (graded from 1=unsatisfactory to 4=Excellent) | 1 day (24h post-surgery) | No | |
Secondary | Six minute walking test distance (m) | 24 months | No | |
Secondary | Short form 36-item quality of life physical function domain score | 24 months | No | |
Secondary | Body mass index (Kg/m2) | 24 months | No |
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