Pulmonary Aspiration in Elderly Patients

Study Overview
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Brief Summary
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The aim of this study was to compare the risk of pulmonary aspiration assessed with gastric ultrasonography in elderly patients, undergoing elective surgery.

Detailed Description
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Recently, carbohydrate loading is suggested for enhanced recovery after surgery. Aging process often accompanies gastrointestinal dysmotility. Therefore, elderly patients might have undiagnosed gastro-esophageal reflux disease, or other gastrointestinal disorders. Moreover, because of their co-morbid underlying diseases and multi-drug effects, gastric emptying might be further delayed in the elderly patients. This study was designated to compared the risk of pulmonary aspiration in elderly patients, with gastric ultrasound between fasting group and carbohydrate loading group.

Official Title
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Comparison of the Risk of Pulmonary Aspiration Assessed by Gastric Ultrasound in Elderly Patients in Fasting Group vs. Carbohydrate Loading Group

Conditions
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Anesthesia

Intervention / Treatment
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* Other: Carbohydrate beverage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged from 65 scheduled for elective surgery American Society of Anesthesiologists physical status 1 or 2 Exclusion Criteria: Diagnosed for diseases that might delay gastric emptying (obesity, diabetes, hiatal hernia, gastro-esophageal reflux disease, ileus) psychiatric or mental disorders delirium dementia parkinsonism alcoholism drug abuse

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Fasting group<br>Participants will be remained fasted until surgery | |
| Experimental: Carbohydrate group<br>Participants will be allowed to drink carbohydrate beverage before 2 hours of surgery | Other: Carbohydrate beverage<br>* The participants in this group are allowed to drink carbohydrate until 2 hours before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of risk of pulmonary aspiration assessed by gastric ultrasound defined by Perlas grade 2 | Incidence of Perlas grade 2. Clear fluid is detected in gastric antrum by gastric antral ultrasound on both supine and right lateral decubitus position. Perlas grade 2: fluid appears in both supine and right lateral decubitus positions Perlas grade 1: fluid is detected only in right decubitus position Perlas grade 0: fluid is not detected in both supine and right lateral decubitus positions. | 2 hours after intake of last allowable carbohydrate drink time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cross-sectional area of gastric antrum in supine position | cross sectional area of gastric antrum is calculated by using the following formula: cross-sectional area = long axis x short axis x 3.14 /4 | 2 hours after intake of last allowable carbohydrate drink time | 
| cross-sectional area of gastric antrum in right decubitus position | cross sectional area of gastric antrum is calculated by using the following formula: cross-sectional area = long axis x short axis x 3.14 /4 | 2 hours after intake of last allowable carbohydrate drink time |