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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
524
Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.
UCSF Fresno Community Regional Medical Center
Fresno, California, United States
University of Southern California (LA County)
Los Angeles, California, United States
Ventilator-free Days (VFDs)
Ventilator-free days (VFDs), defined as the number of days of unassisted breathing to day 28 without having to re-institute invasive ventilation. Patients who died before day 28 were assigned 0 VFDs as were those transferred to a long-term care facility while ventilated.
Time frame: 28 days
All-cause Mortality
All-cause 28 day mortality
Time frame: 28 days
ICU-free Days
Number of ICU-free days to day 28 after enrollment
Time frame: 28 days
Number of Participants With Complications of Treatment
Specifically the number of participants experiencing pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, or pneumatoceles.
Time frame: 28 days
Discharge Status
Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice
Time frame: 28 days
Number of Participants Requiring Oxygen Therapy at Discharge
Number of Participants newly requiring continuous oxygen therapy at discharge.
Time frame: 28 days
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...and 5 more locations