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Table 3 VENT inclusion criteria

From: Design of the Endobronchial Valve for Emphysema Palliation Trial (VENT): a non-surgical method of lung volume reduction

History and physical

Age from 40 to 75 years.

BMI ≤ 31.1 kg/m2 (men) or ≤ 32.3 kg/m2 (women).

Stable with < 20 mg prednisone (or equivalent) daily.

The patient has no child bearing potential OR a negative pregnancy test in a woman of childbearing potential.

HRCT scan

Patient diagnosed by HRCT Core Lab with eligible heterogeneous emphysema.

Pulmonary function

FEV1 < 45% of predicted value.

TLC > 100% predicted.

RV > 150% predicted.

Blood gas

PaCO2 < 50 mm Hg (Denver < 55 mm Hg).

PaO2 > 45 mm Hg (Denver > 30 mm Hg) on room air.

Exercise

Post rehabilitation 6-minute walk of ≥ 140 meters.

Smoking

Nonsmoking for 4 months prior to initial interview and throughout screening.

Plasma continine level < 13.7 ng/ml (or arterial carboxyhemoglobin < 2.5% if using nicotine products).

Consent

Patient has provided written informed consent using a form that has been reviewed and approved by the IRB/EC.

Rehabilitation and follow-up

The patient is willing and able to complete protocol required baseline assessments and procedures.

The patient agrees to all protocol required follow-up intervals.

  1. Abbreviations: BMI = body-mass index, HRCT = high resolution chest computed tomography, FEV1 = forced expiratory volume in one second, TLC = total lung capacity, RV = residual volume, PaO2 = arterial pressure of oxygen, PaCO2 = arterial pressure of carbon dioxide, IRB = institutional review board, EC = Ethics Committee.