Clinical trial NCT02582957: Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome
Official title: Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS
Shock Lung
Acute Chest Syndrome
Respiratory Distress Syndrome, Adult
Respiratory insufficiency
Trauma
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: University of Colorado, Denver
First posted: 2015-10-21
Enrollment: 524
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Ventilator-free Days (VFDs)
timeFrame: 28 days
Secondary outcomes:
measure: All-cause Mortality
timeFrame: 28 days
measure: ICU-free Days
timeFrame: 28 days
measure: Number of Participants With Complications of Treatment
timeFrame: 28 days
measure: Discharge Status
timeFrame: 28 days
measure: Number of Participants Requiring Oxygen Therapy at Discharge
timeFrame: 28 days
Other outcomes:
Locations:
city: Fresno
country: United States
facility: UCSF Fresno Community Regional Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California (LA County)
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Diego
country: United States
facility: UC San Diego Medical Center
state: California
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Baltimore
country: United States
facility: University of Maryland Medical System Shock Trauma Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Austin
country: United States
facility: University Medical Center Brackenridge
state: Texas
city: Dallas
country: United States
facility: UT Southwestern (Parkland)
state: Texas
city: Houston
country: United States
facility: University of Texas Medical School, Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Wauwatosa
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Colorado, Denver
name: Richard Albert, MD
role: PRINCIPAL_INVESTIGATOR
References: