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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Other: Sigh breaths

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: Interventional
• Enrollment (Actual): 524
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93701
      • UCSF Fresno Community Regional Medical Center
    • Los Angeles, California, United States, 90033
      • University of Southern California (LA County)
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • San Diego, California, United States, 92103
      • UC San Diego Medical Center
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Health System
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical System Shock Trauma Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University in St. Louis
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Texas
    • Austin, Texas, United States, 78701
      • University Medical Center Brackenridge
    • Dallas, Texas, United States, 75390
      • UT Southwestern (Parkland)
    • Houston, Texas, United States, 77030
      • University of Texas Medical School, Houston
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator-free days (VFDs)	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).	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause 28 day mortality	28 days
ICU-free days	Number of ICU-free days to day 28 after enrollment	28 days
The occurrence of complications of treatment	Specifically pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, pneumothorax, pneumatocele.	28 days
Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice	Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice	28 days
Newly requiring continuous oxygen therapy at discharge	Newly requiring continuous oxygen therapy at discharge	28 days

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: University of Colorado, Denver; United States Department of Defense
• Investigators: Principal Investigator: Richard Albert, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): October 8, 2022
• Study Completion (Actual): October 8, 2022

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: ARDS; Trauma; Acute Chest Syndrome; Respiratory insufficiency; Respiratory Distress Syndrome, Adult; Shock Lung
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 1512M81688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO