Please select the eligibility criteria that correspond to the clinical trial below.
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
Brief Summary: 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.


Options:
A: Inclusion Criteria:

1. Age: \> 40 and ≤ 75 years old
2. Diagnosis of heterogeneous emphysema with upper lobe predominance
3. FEV1 \< 45% predicted
4. TLC \> 100% predicted
5. RV \> 150% predicted
6. 6-minute walk test \> 140 meters
7. mMRC ≥ 2 (mMRC)
8. Non-smoking for 3 months
9. Optimized medical management and completed pulmonary rehabilitation

Exclusion Criteria:

1. Known α-1-antitrypsin deficiency
2. BMI \< 15 kg/m2 or \> 35 kg / m2
3. History of pneumothorax within previous 18 months
4. History of heart and / or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, and/or lobectomy
5. Respiratory infections or recurring COPD exacerbations \> 3 hospitalizations in past 12 months or active infection
6. History of the (EF) ≤ 40%; Stroke; Unstable Myocardial Ischemia; FEV1 \< 15% predicted; DLCO \< 20% predicted; pulmonary hypertension; indwelling pacemaker or implantable cardiac defibrillator (ICD); pregnancy or breastfeeding
B: Men and women with end-stage emphysema.
C: 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
D: Inclusion Criteria:

* Patients must have a diagnosis of advanced emphysema as defined by FEV1/FVC\<70% predicted, FEV1 of \<50% predicted, TLC \> 100% predicted, and RV \> 135% predicted.
* Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
* Patients must be \> 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.

Exclusion Criteria:

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Answer: C