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Pulmonary Aspiration in Elderly Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04159636
Enrollment
58
Registered
2019-11-12
Start date
2020-01-07
Completion date
2020-08-06
Last updated
2020-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

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

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.

Interventions

The participants in this group are allowed to drink carbohydrate until 2 hours before surgery

Sponsors

Kangbuk Samsung Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of risk of pulmonary aspiration assessed by gastric ultrasound defined by Perlas grade 22 hours after intake of last allowable carbohydrate drink timeIncidence 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.

Secondary

MeasureTime frameDescription
cross-sectional area of gastric antrum in supine position2 hours after intake of last allowable carbohydrate drink timecross sectional area of gastric antrum is calculated by using the following formula: cross-sectional area = long axis x short axis x 3.14 /4
cross-sectional area of gastric antrum in right decubitus position2 hours after intake of last allowable carbohydrate drink timecross sectional area of gastric antrum is calculated by using the following formula: cross-sectional area = long axis x short axis x 3.14 /4

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026