NCT05284084

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Marshall University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-08-03
• Primary completion: 2021-11-02
• Completion: 2021-11-02
• First posted: 2022-03-17
• Last updated: 2023-04-04

Locations

1 site across 1 country: United States