Pulmonary Aspiration in Elderly Patients

NCT ID: NCT04159636

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2020-08-06

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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Fasting group

Participants will be remained fasted until surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Carbohydrate group

Participants will be allowed to drink carbohydrate beverage before 2 hours of surgery

Group Type EXPERIMENTAL

Carbohydrate beverage

Intervention Type OTHER

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

Interventions

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Carbohydrate beverage

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

Intervention Type OTHER

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kangbuk Samsung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eunah Cho, MD

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KBSMC 2019-10-013

Identifier Type: -

Identifier Source: org_study_id