NCT04159636

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 7, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2020

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

November 3, 2019

Last Update Submit

October 27, 2020

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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 in right decubitus position

    2 hours after intake of last allowable carbohydrate drink time

Study Arms (2)

Fasting group

NO INTERVENTION

Participants will be remained fasted until surgery

Carbohydrate group

EXPERIMENTAL

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

Other: Carbohydrate beverage

Interventions

Carbohydrate beverageOTHER

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

Carbohydrate group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • aged from 65
  • scheduled for elective surgery
  • American Society of Anesthesiologists physical status 1 or 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

November 3, 2019

First Posted

November 12, 2019

Study Start

January 7, 2020

Primary Completion

August 6, 2020

Study Completion

August 6, 2020

Last Updated

October 29, 2020

Record last verified: 2020-10

Locations

KR(1)