Table 4.
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 following treatment, and interpreted by the Bronchoscopy investigator (not the 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 |