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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| University of Colorado, Denver | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sigh breaths | Other | Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Albert, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Fresno Community Regional Medical Center | Fresno | California | 93701 | United States | ||
| University of Southern California (LA County) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37877609 | Derived | 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. |
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All analyses were based on the intention-to-treat principle. Participants were included in the primary analysis if primary endpoint data was available (ventilator-free days (VFDs), defined as the number of days of unassisted breathing to day 28 without having to re-institute invasive ventilation).
Patients were recruited in 15 trauma centers in the United States from April, 2016, to September, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Sigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2020 |
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| Number of Participants With Complications of Treatment | Specifically the number of participants experiencing pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, or pneumatoceles. | 28 days |
| Discharge Status | Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice | 28 days |
| Number of Participants Requiring Oxygen Therapy at Discharge | Number of Participants newly requiring continuous oxygen therapy at discharge. | 28 days |
| Los Angeles |
| California |
| 90033 |
| United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| UC San Diego Medical Center | San Diego | California | 92103 | United States |
| Christiana Care Health System | Newark | Delaware | 19713 | United States |
| University of Maryland Medical System Shock Trauma Center | Baltimore | Maryland | 21201 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63130 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| University Medical Center Brackenridge | Austin | Texas | 78701 | United States |
| UT Southwestern (Parkland) | Dallas | Texas | 75390 | United States |
| University of Texas Medical School, Houston | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Medical College of Wisconsin | Wauwatosa | Wisconsin | 53226 | United States |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Sigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Smoking status | Count of Participants | Participants |
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| Arterial blood gas pH | Data based on available medical records | Mean | Standard Deviation | pH |
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| Arterial blood gas PaCO2 | Data based on available medical records | Mean | Standard Deviation | mmHg |
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| Arterial blood gas PaO2 | Data based on available medical records | Mean | Standard Deviation | mmHg |
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| Arterial blood gas FIO2 | Data based on available medical records | Mean | Standard Deviation | mmHg |
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| P/F ratio | Data based on available medical records | Mean | Standard Deviation | Ratio |
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| Hours on ventilator prior to randomization | Mean | Standard Deviation | hours |
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| Injury Severity Score | Score range, 0 (no injury) to 75 (not survivable). | Data based on available medical records | Mean | Standard Deviation | units on a scale |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis based on participants with available follow-up data | Posted | Median | Inter-Quartile Range | days | 28 days |
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| Secondary | All-cause Mortality | All-cause 28 day mortality | Analysis population based on those with follow-up data available | Posted | Count of Participants | Participants | 28 days |
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| Secondary | ICU-free Days | Number of ICU-free days to day 28 after enrollment | Analysis based on participants with available follow-up data | Posted | Median | Inter-Quartile Range | days | 28 days |
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| Secondary | Number of Participants With Complications of Treatment | Specifically the number of participants experiencing pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, or pneumatoceles. | Analysis based on participants with available follow-up data | Posted | Count of Participants | Participants | 28 days |
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| Secondary | Discharge Status | Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice | Posted | Count of Participants | Participants | 28 days |
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| Secondary | Number of Participants Requiring Oxygen Therapy at Discharge | Number of Participants newly requiring continuous oxygen therapy at discharge. | Posted | Count of Participants | Participants | 28 days |
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Participants were followed for 28 days
Events were considered serious if any of the following apply:
Events were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Sigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation. | 30 | 259 | 103 | 259 | 0 | 0 |
| EG001 | 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. | 46 | 261 | 114 | 261 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Other Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Stroke | Vascular disorders | Systematic Assessment |
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| Gastrointestinal Bleed | Gastrointestinal disorders | Systematic Assessment |
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| Cardiovascular | Cardiac disorders | Systematic Assessment |
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| Septic Shock | Infections and infestations | Systematic Assessment |
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| Hypotension | Cardiac disorders | Systematic Assessment |
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| Hemorrhagic Shock | Infections and infestations | Systematic Assessment |
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| Brain Injury | Nervous system disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Albert | University of Colorado | 303-602-5011 | RICHARD.ALBERT@cuanschutz.edu |
| May 3, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D056586 | Acute Chest Syndrome |
| D012131 | Respiratory Insufficiency |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D000755 | Anemia, Sickle Cell |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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