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



Status:Recruiting
Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - 89
Updated:8/18/2018
Start Date:April 2016
End Date:January 2020
Contact:Richard Albert, MD
Email:richard.albert@ucdenver.edu
Phone:303-602-5011

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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.

Inclusion Criteria:

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

Exclusion Criteria:

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).
We found this trial at
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Austin, Texas 78701
Principal Investigator: Carlos VR Brown, MD
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Raminder Nirula, MD
University of Utah Research is a major component in the life of the U benefiting...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Lena Napolitano, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Baltimore, Maryland 21201
Principal Investigator: Deborah Stein, MD, M.P.H.
Phone: 410-328-0288
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Dallas, Texas 75390
Principal Investigator: Joseph Minei, M.D., M.B.A.
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Fresno, California 93701
Principal Investigator: Jim Davis, MD, FACS
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Los Angeles, California 90033
Principal Investigator: Kenji Inaba, MD
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Newark, Delaware 19713
Principal Investigator: Mark Cipolle, MD, PhD
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Palo Alto, California 94304
Principal Investigator: David Spain, MD
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Saint Louis, Missouri 63110
Principal Investigator: Grant Bochicchio, MD, MPH
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