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

NCT05284084 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2023-04-04

No results posted yet for this study

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).

Conditions

  • Bronchial Aspiration

Interventions

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.

OTHER

Data collection for comparison

Data collection for comparison

Sponsors & Collaborators

  • Marshall University

    lead OTHER

Principal Investigators

  • Juan Sanabria, MD MSc FACS · Marshall University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-03
Primary Completion
2021-11-02
Completion
2021-11-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05284084 on ClinicalTrials.gov