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

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:

• Traumatic brain injury
• > 1 long bone fractures
• Shock on arrival in the Emergency Department (systolic BP 6 units of blood

Exclusion Criteria

• Inability to obtain consent from the patient or his/her legally authorized representative (LAR)
• Unwillingness of the treating physician to use sigh ventilation as all treating physicians must have equipoise with respect to the intervention
• Age limitations per Institutional Review Board regulations
• 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
• 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
• Women who are pregnant (negative pregnancy tests required on women of child-bearing age) per Human Subjects regulations
• Prisoners, per Human Subjects regulations
• 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
• 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
• Burns > 40% of body surface area as this could affect the clinical course and cloud interpretation of the endpoints
• 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.
• 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).
• Patient not expected to require mechanical ventilation > 24 hours (e.g., intubated for alcohol intoxication rather than pulmonary problem).