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Completed

NCT Number: NCT04159636

Pulmonary Aspiration in Elderly Patients

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

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Key information

Conditions

Anesthesia

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbohydrate Beverage

Other

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

Primary outcomes

  1. Incidence of risk of pulmonary aspiration assessed by gastric ultrasound defined by Perlas grade 2

    Time frame: 2 hours after intake of last allowable carbohydrate drink time

    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.

Secondary outcomes

  1. cross-sectional area of gastric antrum in supine position

    Time frame: 2 hours after intake of last allowable carbohydrate drink time

    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. cross-sectional area of gastric antrum in right decubitus position

    Time frame: 2 hours after intake of last allowable carbohydrate drink time

    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

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 12, 2019
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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