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OpenTrials
Completed

NCT Number: NCT05284084

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).

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Key information

Conditions

Bronchial Aspiration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marshall University School of Medicine

Huntington, West Virginia, 25701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Data collection for comparison

Other

Data collection for comparison

Primary outcomes

  1. Rate of Bronchospiration pneumonia among study participants during their ICU admission

    Time frame: 12 Months

    Calculating the number of subjects who developed bronchoaspiration pneumonia compared to the total number of ICU admission

Secondary outcomes

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

    Time frame: 12 Months

    Determining the factors impacting the rate of bronchaspiration and the rate of related death

Sponsors and collaborators

Lead sponsor

Marshall University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2022
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.