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

NCT05284084 | Completed

• 1 other identifier: 945673-7
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Patients admitted in the last 3-4 months will have their bed head elevated to 45 degrees + H2 blockers administration + mouth wash BID.

Conditions

Bronchial Aspiration

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determine if there is an association between BA events and death rate in the ICU for the specified time period

  12 Months

Study Arms (3)

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).

Other: Data collection for comparison

Positive Control

ACTIVE COMPARATOR

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

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: * 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

Interventions

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.

Experimental group

Data collection for comparison OTHER

Data collection for comparison

Negative Control; Positive Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marshall University: lead

Study Sites (1)

Marshall University School of Medicine

Huntington, West Virginia, 25701, United States

Location

MeSH Terms

Interventions

Histamine H2 Antagonists; Mouthwashes; Data Collection

Intervention Hierarchy (Ancestors)

Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Biomedical and Dental Materials; Specialty Uses of Chemicals; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Juan Sanabria, MD MSc FACS

  Marshall University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Vice-Chair & Scientific Director

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: March 17, 2022
• Study Start: August 3, 2021
• Primary Completion: November 2, 2021
• Study Completion: November 2, 2021
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)