Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

University of Minnesota - Clinical and Translational Science Institute

Collaborator: University of Colorado, Denver

Stanford Investigator(s):


  • Other: Sigh breaths




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

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).

Ages Eligible for Study

18 Years - 89 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Rosemary Vojnik
Not Recruiting