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

NCT ID: NCT02582957

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 524 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2022-10-08

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.

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sigh breaths

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sigh breaths

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Albert, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

UCSF Fresno Community Regional Medical Center

Fresno, California, United States

University of Southern California (LA County)

Los Angeles, California, United States

University of California Davis Medical Center

Sacramento, California, United States

UC San Diego Medical Center

San Diego, California, United States

Christiana Care Health System

Newark, Delaware, United States

University of Maryland Medical System Shock Trauma Center

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Washington University in St. Louis

St Louis, Missouri, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

University Medical Center Brackenridge

Austin, Texas, United States

UT Southwestern (Parkland)

Dallas, Texas, United States

University of Texas Medical School, Houston

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Medical College of Wisconsin

Wauwatosa, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37877609 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1512M81688

Identifier Type: -

Identifier Source: org_study_id