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Table 4 Survey, Examination Schedule and Clinical Parameters

From: Design of the exhale airway stents for emphysema (EASE) trial: an endoscopic procedure for reducing hyperinflation

Procedure Initial Screening Baseline Testing Procedure Day Post-Procedure Days 1-2 Month 1 ± 7 days Month 3 ± 14 days Month 6 ± 14 days Month 12 ± 14 days Years 2-5 ± 60 days (treated subjects)
Health Inventory   X   X X X X X X
HRCT Scan performed in certified scanner X1    X5    X X7  
Chest X-Ray X2   X5       
Pulmonary Rehabilitation - Supervised 16-20 sessions over 6-10 weeks   After discharge for 8-9 weeks    
Cotinine, carboxyhemoglobin, or carbon monoxide X2 X3     X    
Photograph X2   X    X   
Blinding assessment questionnaire     X X X X X  
St. George's Respiratory Questionnaire   X3    X X X X X
Quality of Well-being scale   X3    X X X X X
Medical History (or interval history) X2     X X X X X
ASAPSC (Anesthesia score)   X        
Dyspnea Index (modified mMRC) X2 X3   X X X X X X
Physical Exam, to include RR, HR, SpO2   X3    X X X X X
Electrocardiogram   X3        
Spirometry X2 X3   X X X X X X
Body Plethysmography X2 X3   X X X X X X
DLco X2 X3    X X X X  
Echocardiography to rule out pulmonary hypertension and congestive heart failure X2         
Pregnancy test (women of child-bearing age)   X4       
CBC, Blood Chemistry Panel   X3    X X X X  
PTT/INR/PT (only if on acticoagulation therapy)   X3        
Serum Creatinine   X3        
Arterial Blood Gases X2 X3      X   
6-Minute Walk (with BORG scores)   X3    X X X X  
Cycle Ergometry (work output)   X3      X   
Intraveneous antibiotic    X       
Begin aspirin    X (post op)       
Begin oral antibiotic and give subject pocket ID card     X      
1 Within 6 months prior to randomization 5 As soon as possible followingtreatment, and interpreted by the Bronchoscopy investigator (notthe Assessment investigator)
2 Within 4 months prior to randomization  
3 Within 4 weeks prior to randomization and following at least 6 weeks of supervised pulmonary rehabilitation 6 Required pre- and post-op.
4 Within 24-hours prior to intervention day 7 CT scan at 12 months for Airway Bypass subjects only