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

Marshall University

Status: Completed

Conditions: Bronchial Aspiration

Treatments: Other: Data collection for comparison; Other: Bed Head elevation, H2 blockers and mouth wash

Study type: Interventional

Funder types: Other

Identifiers

NCT05284084

945673-7

Details and patient eligibility

About

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).

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 3 patient groups, including a placebo group

Negative Control

Placebo Comparator group

Description:

Matched subjects by age, sex and BMI with no BA events, from a pool of 20,032 admission (01JAN2010 to 31DEC2019).

Treatment:

Other: Data collection for comparison

Positive Control

Active Comparator group

Description:

Matched subjects by age, sex and BMI with BA events, from a pool of 20,032 admission (01JAN2010 to 31DEC2019).

Treatment:

Other: Data collection for comparison

Experimental group

Experimental group

Description:

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

Treatment:

Other: Bed Head elevation, H2 blockers and mouth wash