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Bed Head elevation, H2 blockers and mouth wash for Bronchial Aspiration
N/A
Waitlist Available
Led By Juan Sanabria, MD MSc FACS
Research Sponsored by Marshall University
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 12 months
Awards & highlights
Study Summary
This trial will study whether different degrees of bed head elevation will impact the rate of GI complications in patients admitted to the ICU.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Bronchospiration pneumonia among study participants during their ICU admission
Secondary outcome measures
Determine if there is an association between BA events and death rate in the ICU for the specified time period
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Experimental groupExperimental Treatment1 Intervention
Consecutive subjects admitted to the ICU (these subjects will be matched with historical controls with and without BA events) from 30MAR2021 to 30MAR2022 on three subgroups:
Head up from the bed 15 degrees + H2 blockers + mouth wash BID
Head up from the bed 30 degrees + H2 blockers + mouth wash BID
Head up from the bed 45 degrees + H2 blockers + mouth wash BID
Group II: Positive ControlActive Control1 Intervention
Matched subjects by age, sex and BMI with BA events, from a pool of 20,032 admission (01JAN2010 to 31DEC2019).
Group III: Negative ControlPlacebo Group1 Intervention
Matched subjects by age, sex and BMI with no BA events, from a pool of 20,032 admission (01JAN2010 to 31DEC2019).
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Who is running the clinical trial?
Marshall UniversityLead Sponsor
20 Previous Clinical Trials
4,003 Total Patients Enrolled
Juan Sanabria, MD MSc FACSPrincipal InvestigatorMarshall University School of Medicine
1 Previous Clinical Trials
100 Total Patients Enrolled
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