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

Completed · Not applicable

Conditions studied: Acute Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT02582957

Run by

University of Minnesota

People needed

524

Starts

2016-04-01

Expected to finish

2022-10-08

Last updated by the study team

2024-06-06

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• UCSF Fresno Community Regional Medical Center — Fresno, California, United States
• University of Southern California (LA County) — Los Angeles, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• UC San Diego Medical Center — San Diego, California, United States
• Christiana Care Health System — Newark, Delaware, United States
• University of Maryland Medical System Shock Trauma Center — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• University Medical Center Brackenridge — Austin, Texas, United States
• UT Southwestern (Parkland) — Dallas, Texas, United States
• University of Texas Medical School, Houston — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Medical College of Wisconsin — Wauwatosa, Wisconsin, United States

Full record on ClinicalTrials.gov

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