|Age:||18 to 89 years old|
|Keywords:||Acute Respiratory Distress Syndrome|
Participating in the study will require no additional tests or procedures other than what is part of your standard medical care.
You will be put into one of two groups of patients. The choice of which group you will be in will be decided completely by chance (for example, by flipping a coin). Both groups of patients will receive the type of care their doctor believes is necessary. If you are assigned to the first group of patients, your doctor will adjust the breathing machine the way your doctor believes it should be set.
If you are in the second group of patients, your doctor will adjust the breathing machine the way your doctor believes it should be set. Also, the machine will be set to deliver one large breath (a sigh) every six minutes.
You will receive your assigned study treatment any time you need a breathing machine during the 28 day study period.
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
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).
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.