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NCT04159636 Clinical Trial

Pulmonary Aspiration in Elderly Patients

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04159636
Other study ID # KBSMC 2019-10-013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 7, 2020
Est. completion date August 6, 2020

Study information
Verified date October 2020
Source Kangbuk Samsung Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date August 6, 2020
Est. primary completion date August 6, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Carbohydrate beverage
The participants in this group are allowed to drink carbohydrate until 2 hours before surgery

Locations
Country Name City State
Korea, Republic of Kangbuk Samsung Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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