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

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).

Study Overview

• Status: Completed
• Conditions: Bronchial Aspiration
• Intervention / Treatment: Other: Data collection for comparison; Other: Bed Head elevation, H2 blockers and mouth wash

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Marshall University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Negative Control; Matched subjects by age, sex and BMI with no BA events, from a pool of 20,032 admission (01JAN2010 to 31DEC2019).	Other: Data collection for comparison; Data collection for comparison
Active Comparator: Positive Control; Matched subjects by age, sex and BMI with BA events, from a pool of 20,032 admission (01JAN2010 to 31DEC2019).	Other: Data collection for comparison; Data collection for comparison
Experimental: 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	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Marshall University

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Actual): November 2, 2021
• Study Completion (Actual): November 2, 2021

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; ICU; Aspiration; Intensive Care Unit; Surgical patients; Bronchial; Bronchoaspiration; Broncho-aspiration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists
• Other Study ID Numbers: 945673-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No