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. 2011 Jan 7;11:1. doi: 10.1186/1471-2466-11-1

Table 4.

Survey, Examination Schedule and Clinical Parameters

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