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Pulmonary Aspiration in Elderly Patients

Sponsor
Kangbuk Samsung Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04159636
Collaborator
(none)
58
Enrollment
1
Location
2
Arms
7
Actual Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Carbohydrate beverage
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Comparison of the Risk of Pulmonary Aspiration Assessed by Gastric Ultrasound in Elderly Patients in Fasting Group vs. Carbohydrate Loading Group
Actual Study Start Date :
Jan 7, 2020
Actual Primary Completion Date :
Aug 6, 2020
Actual Study Completion Date :
Aug 6, 2020

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Fasting group

Participants will be remained fasted until surgery
Experimental: Carbohydrate group

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181

Sponsors and Collaborators

  • Kangbuk Samsung Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eunah Cho, MD, Clinical Assistant Professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier:
NCT04159636
Other Study ID Numbers:
  • KBSMC 2019-10-013
First Posted:
Nov 12, 2019
Last Update Posted:
Oct 29, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 29, 2020