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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome: Ventilator-free days (VFDs) [ Time Frame: 28 days ]

The difference between 28 and the day the patient was removed from any form of mechanical ventilation (i.e., invasive, non-invasive, continuous or intermittent).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • All-cause mortality [ Time Frame: 28 days ]
  • ICU-free days [ Time Frame: 28 days ]
  • The occurrence of complications of treatment [ Time Frame: 28 days ]
    Specifically pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, pneumothorax, pneumatocele.
  • Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice [ Time Frame: 28 days ]
  • Newly requiring continuous oxygen therapy at discharge [ Time Frame: 28 days ]


Original Secondary Outcome:

  • All-cause mortality [ Time Frame: 28 days ]
  • ICU-free days [ Time Frame: 28 days ]
  • The occurrence of complications of treatment [ Time Frame: 28 days ]
    Specifically pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, pneumothorax, pneumatocele.
  • Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice [ Time Frame: 28 days ]


Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: October 19, 2015
Date Started: April 2016
Date Completion: January 2020
Last Updated: April 21, 2017
Last Verified: April 2017