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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia

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