A randomized, concurrent controlled trial to assess if adding sigh breaths to usual invasive mechanical ventilation of victims of trauma who are at risk of developing ARDS will decrease the number of days they require invasive mechanical ventilation.
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.
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 < 90 mmHg)
Receipt of> 6 units of blood
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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).
UCSF Fresno Community Regional Medical Centeraccepting new patients Fresno, California, 93701, United States
Stanford Universityaccepting new patients Palo Alto, California, 94304, United States
University of Southern California (LA County)accepting new patients Los Angeles, California, 90033, United States
accepting new patients
University of Minnesota - Clinical and Translational Science Institute