Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome

Patients in intensive care units (ICUs) as a result of injuries resulting from penetrating or
non-penetrating trauma who are intubated and receiving invasive mechanical ventilation will
be randomized to either usual care or usual care with the addition of sigh breaths given once
every 6 minutes. Patients will be randomized to one of the two study arms as soon as
possible, but not longer than 24 hours after initiation of invasive mechanical ventilation.
Patients will be followed for 28 days to assess ventilator-free days (VFDs), mortality,
ICU-free days, and the occurrence of complications.

Inclusion Criteria:

Patients in an intensive care unit (ICU) as a result of injuries resulting from penetrating
or non-penetrating trauma who are intubated and receiving invasive mechanical ventilation
who also have one or more of the following:

1. Traumatic brain injury

2. > 1 long bone fractures

3. Shock on arrival in the Emergency Department (systolic BP < 90 mmHg)

4. Lung contusion

5. Receipt of > 6 units of blood

Exclusion Criteria:

1. Inability to obtain consent from the patient or his/her legally authorized
representative (LAR)

2. Unwillingness of the treating physician to use sigh ventilation as all treating
physicians must have equipoise with respect to the intervention

3. Age limitations per Institutional Review Board regulations

4. Undergoing invasive mechanical ventilation for > 24 hours, excluding any time during
which the patient was being ventilated in the operating room, CT or IR, as this could
represent too long a delay in instituting the intervention for it to have a chance of
being effective

5. Presence of malignancy or other irreversible disease or condition for which the six
month mortality is estimated to exceed 50% (e.g., chronic liver disease with a
Child-Pugh Score of 10-15, malignancy refractory to treatment) as this could affect
the clinical course and cloud interpretation of the endpoints

6. Women who are pregnant (negative pregnancy tests required on women of child-bearing
age) per Human Subjects regulations

7. Prisoners, per Human Subjects regulations

8. Neurological condition that could impair spontaneous ventilation (e.g., C5 or higher
spinal cord injury as this could affect the clinical course and cloud interpretation
of the ventilator-free day endpoint

9. Lack of availability of Dräger Evita Infinity V500 ventilator as this is the only
ventilator capable of delivering sigh breaths as described in the protocol

10. Burns > 40% of body surface area as this could affect the clinical course and cloud
interpretation of the endpoints

11. Treating physicians being unwilling to use low VT ventilation strategy when ARDS is
diagnosed as low VT ventilation is now considered standard of care for patients with
ARDS.

12. Moribund, not expected to survive 24 hours as this could affect the clinical course
and cloud interpretation of the endpoints13. Treating physician's decision to use
airway pressure release ventilation (APRV).

13. Patient not expected to require mechanical ventilation > 24 hours (e.g., intubated for
alcohol intoxication rather than pulmonary problem).