Prevention of Broncho-aspiration (BA) in Adult Subjects During Their ICU Stay
NCT ID: NCT05284084
Last Updated: 2023-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
159 participants
INTERVENTIONAL
2021-08-03
2021-11-02
Brief Summary
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1. Patients admitted to the ICU in the first 3-4 months will have their bed head elevated to 15 degrees + H2 blockers administration + mouth wash BID
2. Patients admitted to the ICU in the following 3-4 months will have their bed head elevated to 30 degrees + H2 blockers administration + mouth wash BID
3. Patients admitted in the last 3-4 months will have their bed head elevated to 45 degrees + H2 blockers administration + mouth wash BID.
All patients will have their vital signs, BMI, and fluids ins and outs measured every 24 hours until the discharge from the ICU or death. All patients will be evaluated for GI functions (no vomiting, flatus+, bowel movement +, bowel sounds+, and KUB with normal gas distribution pattern) prior to oral intake.
Patients in the three groups will be matched by age, sex, and BMI with historical controls with broncho- aspiration (BA) (positive controls) and without BA events (negative controls) from a pool of 20,032 ICU admissions (01JAN2010 to 31DEC2019).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Negative Control
Matched subjects by age, sex and BMI with no BA events, from a pool of 20,032 admission (01JAN2010 to 31DEC2019).
Data collection for comparison
Data collection for comparison
Positive Control
Matched subjects by age, sex and BMI with BA events, from a pool of 20,032 admission (01JAN2010 to 31DEC2019).
Data collection for comparison
Data collection for comparison
Experimental group
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
Bed Head elevation, H2 blockers and mouth wash
Elevation of the bed head to 15, 30 and 45 degrees, daily H2 blockers administration and mouth wash BID.
Interventions
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Bed Head elevation, H2 blockers and mouth wash
Elevation of the bed head to 15, 30 and 45 degrees, daily H2 blockers administration and mouth wash BID.
Data collection for comparison
Data collection for comparison
Eligibility Criteria
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Inclusion Criteria
* All the patients admitted to ICU by surgery department.
* Development of aspiration pneumonia in patients admitted to ICU department of VA hospital.
* Aspiration Pneumonia development during hospital stay and treating physician indicated the diagnosis of aspiration pneumonia in history and physical exam notes.
Exclusion Criteria
* Patient transferred or admitted to the hospital as a primary diagnosis of aspiration pneumonia (development of aspiration pneumonia prior to admission).
* Treating physician not documented aspiration pneumonia in history or physical exam notes.
* Drug overdose, seizure or cardiopulmonary arrest prior to hospital admission.
18 Years
ALL
No
Sponsors
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Marshall University
OTHER
Responsible Party
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Juan Sanabria
Professor of Surgery, Vice-Chair & Scientific Director
Principal Investigators
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Juan Sanabria, MD MSc FACS
Role: PRINCIPAL_INVESTIGATOR
Marshall University School of Medicine
Locations
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Marshall University School of Medicine
Huntington, West Virginia, United States
Countries
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Other Identifiers
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945673-7
Identifier Type: -
Identifier Source: org_study_id
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