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

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ClinicalTrials.gov Identifier: NCT02582957
Recruitment Status : Recruiting
First Posted : October 21, 2015
Last Update Posted : January 13, 2021
Sponsor:
Collaborators:
United States Department of Defense
University of Colorado, Denver
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE October 19, 2015
First Posted Date  ICMJE October 21, 2015
Last Update Posted Date January 13, 2021
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2015)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
  • All-cause mortality [ Time Frame: 28 days ]
    All-cause 28 day mortality
  • ICU-free days [ Time Frame: 28 days ]
    Number of ICU-free days to day 28 after enrollment
  • The occurrence of complications of treatment [ Time Frame: 28 days ]
    Specifically pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, pneumothorax, pneumatocele.
  • 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
  • Newly requiring continuous oxygen therapy at discharge [ Time Frame: 28 days ]
    Newly requiring continuous oxygen therapy at discharge
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2015)
  • All-cause mortality [ Time Frame: 28 days ]
  • ICU-free days [ Time Frame: 28 days ]
  • The occurrence of complications of treatment [ Time Frame: 28 days ]
    Specifically pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, pneumothorax, pneumatocele.
  • Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice [ Time Frame: 28 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome
Official Title  ICMJE Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Acute Respiratory Distress Syndrome
Intervention  ICMJE Other: Sigh breaths
Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Sigh breaths
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2020)
544
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2015)
916
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Richard Albert, MD 303-602-5011 richard.albert@ucdenver.edu
Contact: Sarah Lindberg, MPH 612-626-9011 slindberg@umn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02582957
Other Study ID Numbers  ICMJE 1512M81688
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE
  • United States Department of Defense
  • University of Colorado, Denver
Investigators  ICMJE
Principal Investigator: Richard Albert, MD University of Colorado, Denver
PRS Account University of Minnesota
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP