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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