Skip to main content

Summary

for people ages 18–89 (full criteria)
at Fresno, California and other locations
study started
estimated completion:
Jim Davis

Description

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.

Details

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.

Keywords

Acute Respiratory Distress Syndrome ARDS Shock Lung Acute Chest Syndrome Respiratory Distress Syndrome, Adult Respiratory insufficiency Trauma

Eligibility

You can join if…

Open to people ages 18–89

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:

  1. Traumatic brain injury
  2. > 1 long bone fractures
  3. Shock on arrival in the Emergency Department (systolic BP < 90 mmHg)
  4. Lung contusion
  5. Receipt of > 6 units of blood

You CAN'T join if...

  1. Inability to obtain consent from the patient or his/her legally authorized representative (LAR)
  2. Unwillingness of the treating physician to use sigh ventilation as all treating physicians must have equipoise with respect to the intervention
  3. Age limitations per Institutional Review Board regulations
  4. 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
  5. 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
  6. Women who are pregnant (negative pregnancy tests required on women of child-bearing age) per Human Subjects regulations
  7. Prisoners, per Human Subjects regulations
  8. 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
  9. 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
  10. . Burns > 40% of body surface area as this could affect the clinical course and cloud interpretation of the endpoints
  11. . 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.
  12. . 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).
  13. . Patient not expected to require mechanical ventilation > 24 hours (e.g., intubated for alcohol intoxication rather than pulmonary problem).

Locations

  • Stanford University accepting new patients
    Palo Alto, California, 94304, United States
  • University of Southern California (LA County) accepting new patients
    Los Angeles, California, 90033, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Minnesota - Clinical and Translational Science Institute
ID
NCT02582957
Lead Scientist
Jim Davis
Study Type
Interventional
Last Updated
April 1, 2017
I’m interested in this study!