Study to Determine if Using Ventilation During Open Heart Surgery Improves Lung Outcomes

This is a prospective, randomized, blinded study with a control group. The study group will
receive mechanical ventilatory support during CBB, which consists of a preset/predetermined
tidal volume, respiratory rate, positive pressure at the end of expiration and FIO2. The
control group will receive CPB without additional mechanical ventilatory support during
surgery, which at present is the standard of care.

The difference between the study and the control group will occur during the time the heart
is arrested and the lungs, under present standard of care, are no longer ventilated. It is at
this point in time that those in the study group will continue to receive ventilation,
intermittent positive pressure ventilation, while their heart is arrested. The subjects will
have their lungs ventilated six times per minute with a tidal volume equal to 7-10
milliliters per kilogram. This range, when combined with a consistent PEEP of 5cm of water
pressure, will allow for the peak inspiratory pressure to be maintained at or below 40cm of
water pressure. In addition, the FIO2 will remain consistent at the same level that was
needed to maintain the pulse oximetry at 94% as well as the end-tidal CO2 at 35mmHg. The
values mentioned for this study have been chosen based on not only investigator preference,
but also on what is considered "minimally necessary" to prevent atelectasis. Multiple studies
have been done utilizing PEEP at 5 and 10 cm of water pressure. With the exception of the
potential for mechanical ventilation during the CBP, the care of the subject, regardless of
the group randomized into, will be the same. We will in all other aspects continue to utilize
the current standard of care.

Inclusion Criteria:

- any patient of any gender, any age with known coronary artery disease that will
undergo elective Coronary Artery Bypass Grafting (CABG) and will require CPB as part
of his/her operative technique.

Exclusion Criteria:

- documented ejection fraction (either by echocardiogram or by cardiac catheterization)
equal to or below 20%

- patients with cardiac valvular disease

- patients with a spirometry measurement that demonstrates an FEV1/FVC ratio below 60%

- patients with chronic renal failure who require dialysis or

- those who have experienced an allergic reaction to anesthesia in the past

- patients with a history of lung infiltrate on chest X-ray prior to surgery or a
history of asthma

- Women who are pregnant are excluded