Skip to content

Prevention of Broncho-aspiration (BA) in Adult Subjects During Their ICU Stay

Prevention of Broncho-aspiration (BA) in Adult Subjects During Their ICU Stay

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05284084
Enrollment
159
Registered
2022-03-17
Start date
2021-08-03
Completion date
2021-11-02
Last updated
2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Aspiration

Keywords

Bronchial, Aspiration, Bronchoaspiration, Broncho-aspiration, ICU, Intensive Care Unit, Surgical patients, Surgery

Brief summary

Patients of age \>18 yo, admitted to the ICU through the surgery department from 2AUG2021 to 1AUG2022 will be divided into three groups: 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).

Interventions

OTHERBed 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.

OTHERData collection for comparison

Data collection for comparison

Sponsors

Marshall University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age\>18 * 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

* Age \<18 * 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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of Bronchospiration pneumonia among study participants during their ICU admission12 MonthsCalculating the number of subjects who developed bronchoaspiration pneumonia compared to the total number of ICU admission

Secondary

MeasureTime frameDescription
Determine if there is an association between BA events and death rate in the ICU for the specified time period12 MonthsDetermining the factors impacting the rate of bronchaspiration and the rate of related death

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026