NCT04789785

Brief Summary

DETERMINING GASTRIC EMPTYING TIME IN ELDERLY USING ULTRASOUND ASSOCIATED WITH PREOPERATIVE FASTING TIME Background: Gastric contents aspiration is the most crucial complication of general anaesthesia. There are limited studies to assess the gastric volume ultrasound to clarify an appropriate fasting time before surgery. Gastric content will examine after a traditional Turkish breakfast with ultrasound. Methods: After the first ultrasound examination by asking 8 hours fasting ,gastric emptying time(GET) was determined by serial gastric ultrasound examinations with two ultrasonographers and GET identified by real time USG evaluations in every 1 hour. All ultrasound assessments on volunteers will made both in the supine position and right lateral decubitus (RLD) from the epigastric area by using a convex probe. This study is the first one which examine gastric emptying time after a standard Turkish breakfast in over 65 years Turkish population by measuring antral cross section area (CSA) using noninvasive ultrasound.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

February 22, 2021

Last Update Submit

March 8, 2021

Conditions

Keywords

gastric contentgastric ultrasonographypreoperative fasting

Outcome Measures

Primary Outcomes (1)

  • evaluating gastric emptying time assosiated with preoperative fasting

    By measuring gastric cross section area using ultrasound to find the emptying time about 6 hours

    base and real time measurements for 6 hours by 1 hour intervals

Interventions

ultrasoundDIAGNOSTIC_TEST

observation with usg

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

over 65 years of age Turkish volunteers without comorbity

You may qualify if:

  • over 65 years of age who have not any comorbidities

You may not qualify if:

  • gastrointestinal and functional disorders, previous oesophageal or upper abdomen surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpaşa TREH

Istanbul, Gaziosmanpaşa, 34255, Turkey (Türkiye)

Location

Related Publications (2)

  • Soenen S, Rayner CK, Horowitz M, Jones KL. Gastric Emptying in the Elderly. Clin Geriatr Med. 2015 Aug;31(3):339-53. doi: 10.1016/j.cger.2015.04.003. Epub 2015 May 11.

    PMID: 26195094BACKGROUND
  • Bolondi L, Bortolotti M, Santi V, Calletti T, Gaiani S, Labo G. Measurement of gastric emptying time by real-time ultrasonography. Gastroenterology. 1985 Oct;89(4):752-9. doi: 10.1016/0016-5085(85)90569-4.

    PMID: 3896910BACKGROUND

MeSH Terms

Conditions

Fasting

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

February 22, 2021

First Posted

March 10, 2021

Study Start

January 5, 2021

Primary Completion

February 20, 2021

Study Completion

February 20, 2021

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations