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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02582957
Recruitment Status : Suspended (All sites suspended because of the COVID pandemic.)
First Posted : October 21, 2015
Last Update Posted : April 27, 2020
Sponsor:
Collaborators:
United States Department of Defense
University of Colorado, Denver
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Other: Sigh breaths Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 544 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome
Study Start Date : April 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Sigh breaths
Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs > 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation.
Other: Sigh breaths
Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.

No Intervention: Usual Care
Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.



Primary Outcome Measures :
  1. Ventilator-free days (VFDs) [ Time Frame: 28 days ]
    The difference between 28 and the day the patient was removed from any form of mechanical ventilation (i.e., invasive, non-invasive, continuous or intermittent).


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 28 days ]
    All-cause 28 day mortality

  2. ICU-free days [ Time Frame: 28 days ]
    Number of ICU-free days to day 28 after enrollment

  3. The occurrence of complications of treatment [ Time Frame: 28 days ]
    Specifically pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, pneumothorax, pneumatocele.

  4. Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice [ Time Frame: 28 days ]
    Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice

  5. Newly requiring continuous oxygen therapy at discharge [ Time Frame: 28 days ]
    Newly requiring continuous oxygen therapy at discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582957


Locations
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United States, California
UCSF Fresno Community Regional Medical Center
Fresno, California, United States, 93701
University of Southern California (LA County)
Los Angeles, California, United States, 90033
University of California Davis Medical Center
Sacramento, California, United States, 95817
UC San Diego Medical Center
San Diego, California, United States, 92103
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19713
United States, Maryland
University of Maryland Medical System Shock Trauma Center
Baltimore, Maryland, United States, 21201
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63130
United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Texas
University Medical Center Brackenridge
Austin, Texas, United States, 78701
UT Southwestern (Parkland)
Dallas, Texas, United States, 75390
University of Texas Medical School, Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Wisconsin
Medical College of Wisconsin
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Minnesota
United States Department of Defense
University of Colorado, Denver
Investigators
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Principal Investigator: Richard Albert, MD University of Colorado, Denver
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02582957    
Other Study ID Numbers: 1512M81688
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Minnesota:
ARDS
Shock Lung
Acute Chest Syndrome
Respiratory Distress Syndrome, Adult
Respiratory insufficiency
Trauma
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury