Acute Respiratory Distress SyndromeSiVentNCT02582957
Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome
A study testing Sigh breaths in people with Acute Respiratory Distress Syndrome, run by University of Minnesota at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Sigh breaths
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Apr 2016to 8 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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).
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Michigan
Ann Arbor, Michigan, 48109
University Medical Center Brackenridge
Austin, Texas, 78701
University of Maryland Medical System Shock Trauma Center
Baltimore, Maryland, 21201
UT Southwestern (Parkland)
Dallas, Texas, 75390
Henry Ford Hospital
Detroit, Michigan, 48202
UCSF Fresno Community Regional Medical Center
Fresno, California, 93701
University of Texas Medical School, Houston
Houston, Texas, 77030
University of Southern California (LA County)
Los Angeles, California, 90033
Christiana Care Health System
Newark, Delaware, 19713
University of California Davis Medical Center
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84132
UC San Diego Medical Center
San Diego, California, 92103
Washington University in St. Louis
St Louis, Missouri, 63130
Medical College of Wisconsin
Wauwatosa, Wisconsin, 53226
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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
- Being tested
- Sigh breaths
- Keywords
- ARDS, Shock Lung, Acute Chest Syndrome, Respiratory Distress Syndrome, Adult, Respiratory insufficiency, Trauma
- Medical subject headings
- Respiratory Distress Syndrome, Acute Chest Syndrome, Respiratory Insufficiency, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sigh breathsOther
Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (5)
All-cause Mortality
All-cause 28 day mortality
Measured: 28 days
ICU-free Days
Number of ICU-free days to day 28 after enrollment
Measured: 28 days
Number of Participants With Complications of Treatment
Specifically the number of participants experiencing pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, or pneumatoceles.
Measured: 28 days
Discharge Status
Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice
Measured: 28 days
Number of Participants Requiring Oxygen Therapy at Discharge
Number of Participants newly requiring continuous oxygen therapy at discharge.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start1 Apr 2016
- Primary completion8 Oct 2022
- Study completion8 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Richard Albert, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582957
- Sponsor's protocol ID
- 1512M81688
- Acronym
- SiVent
- Status last verified
- May 2024
- First submitted
- 19 Oct 2015
- Last updated
- 6 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37877609
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02582957
- Acronym / sponsor ID
- SiVent / 1512M81688
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, Shock Lung, Acute Chest Syndrome, Respiratory Distress Syndrome, Adult, Respiratory insufficiency, Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- United States Department of Defense, University of Colorado, Denver
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 8 Oct 2022 (actual)
- Study completion
- 8 Oct 2022 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sigh breaths | Experimental | Other: Sigh breathsSigh 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sigh breathsSigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation. | Other | Sigh breaths |
Primary outcome
Ventilator-free Days (VFDs)
Time frame: 28 days
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.
5 secondary outcomes
All-cause Mortality
Time frame: 28 days
ICU-free Days
Time frame: 28 days
Number of Participants With Complications of Treatment
Time frame: 28 days
Discharge Status
Time frame: 28 days
Number of Participants Requiring Oxygen Therapy at Discharge
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37877609Albert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Albert, MD principal investigator
University of Colorado, Denver
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sigh breaths in people with Acute Respiratory Distress Syndrome, run by University of Minnesota at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free Days (VFDs) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02582957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.