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Sigh breaths for Acute Respiratory Distress Syndrome (SiVent Trial)
N/A
Waitlist Available
Led By Richard Albert, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
SiVent Trial Summary
This trial will assess if adding sigh breaths to usual invasive mechanical ventilation will decrease the number of days patients require mechanical ventilation.
Eligible Conditions
- Acute Respiratory Distress Syndrome
SiVent Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ventilator-free days (VFDs)
Secondary outcome measures
All-cause mortality
ICU-free days
Newly requiring continuous oxygen therapy at discharge
+2 moreSiVent Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sigh breathsExperimental Treatment1 Intervention
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 II: Usual CareActive Control1 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.
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,375 Previous Clinical Trials
1,587,851 Total Patients Enrolled
United States Department of DefenseFED
859 Previous Clinical Trials
224,974 Total Patients Enrolled
University of Colorado, DenverOTHER
1,731 Previous Clinical Trials
2,144,073 Total Patients Enrolled
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