Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients of age >18 yo, admitted to the ICU through the surgery department from 2AUG2021 to 1AUG2022 will be divided into three groups:
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Control | Placebo Comparator | Matched subjects by age, sex and BMI with no BA events, from a pool of 20,032 admission (01JAN2010 to 31DEC2019). |
|
| Positive Control | Active Comparator | Matched subjects by age, sex and BMI with BA events, from a pool of 20,032 admission (01JAN2010 to 31DEC2019). |
|
| Experimental group | Experimental | 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bed Head elevation, H2 blockers and mouth wash | Other | Elevation of the bed head to 15, 30 and 45 degrees, daily H2 blockers administration and mouth wash BID. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Bronchospiration pneumonia among study participants during their ICU admission | Calculating the number of subjects who developed bronchoaspiration pneumonia compared to the total number of ICU admission | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine if there is an association between BA events and death rate in the ICU for the specified time period | Determining the factors impacting the rate of bronchaspiration and the rate of related death | 12 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juan Sanabria, MD MSc FACS | Marshall University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marshall University School of Medicine | Huntington | West Virginia | 25701 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006635 | Histamine H2 Antagonists |
| D009067 | Mouthwashes |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D006633 | Histamine Antagonists |
| D018494 | Histamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Data collection for comparison | Other | Data collection for comparison |
|
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D003358 | Cosmetics |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |