Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respirat… (NCT02582957) | Clinical Trial Compass
CompletedNot Applicable
Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome
United States524 participantsStarted 2016-04-01
Plain-language summary
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.
Who can participate
Age range18 Years – 89 Years
SexALL
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Inclusion criteria
✓. Traumatic brain injury
✓. \> 1 long bone fractures
✓. Shock on arrival in the Emergency Department (systolic BP \< 90 mmHg)
✓. Lung contusion
✓. Receipt of \> 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
✕. 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