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

NCT02582957 | Completed Results DMC

• 1 other identifier: 1512M81688
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 15

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS; Shock Lung; Acute Chest Syndrome; Respiratory Distress Syndrome, Adult; Respiratory insufficiency; Trauma

Outcome Measures

Primary Outcomes (1)

• Ventilator-free Days (VFDs)

  Ventilator-free days (VFDs), defined as the number of days of unassisted breathing to day 28 without having to re-institute invasive ventilation. Patients who died before day 28 were assigned 0 VFDs as were those transferred to a long-term care facility while ventilated.

  28 days

Secondary Outcomes (5)

• All-cause Mortality

  28 days

• ICU-free Days

  28 days

• Number of Participants With Complications of Treatment

  28 days

• Discharge Status

  28 days

• Number of Participants Requiring Oxygen Therapy at Discharge

  28 days

Study Arms (2)

Sigh breaths

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Sigh breaths OTHER

Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.

Sigh breaths

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of Minnesota: lead
• United States Department of Defense: collaborator
• University of Colorado, Denver: collaborator

Study Sites (15)

UCSF Fresno Community Regional Medical Center

Fresno, California, 93701, United States

Location

University of Southern California (LA County)

Los Angeles, California, 90033, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

UC San Diego Medical Center

San Diego, California, 92103, United States

Location

Christiana Care Health System

Newark, Delaware, 19713, United States

Location

University of Maryland Medical System Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University Medical Center Brackenridge

Austin, Texas, 78701, United States

Location

UT Southwestern (Parkland)

Dallas, Texas, 75390, United States

Location

University of Texas Medical School, Houston

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Medical College of Wisconsin

Wauwatosa, Wisconsin, 53226, United States

Location

Related Publications (1)

• Albert RK, Jurkovich GJ, Connett J, Helgeson ES, Keniston A, Voelker H, Lindberg S, Proper JL, Bochicchio G, Stein DM, Cain C, Tesoriero R, Brown CVR, Davis J, Napolitano L, Carver T, Cipolle M, Cardenas L, Minei J, Nirula R, Doucet J, Miller PR, Johnson J, Inaba K, Kao L. Sigh Ventilation in Patients With Trauma: The SiVent Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1982-1990. doi: 10.1001/jama.2023.21739.

  PMID: 37877609 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Chest Syndrome; Respiratory Insufficiency; Wounds and Injuries

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Richard Albert
• Organization: University of Colorado

RICHARD.ALBERT@cuanschutz.edu

303-602-5011

Study Officials

• Richard Albert, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 21, 2015
• Study Start: April 1, 2016
• Primary Completion: October 8, 2022
• Study Completion: October 8, 2022
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)