NCT04288466

Brief Summary

Gastric volume will be measured before, 5, 30, 60, 90 and 120 min after drinking 450ml of maltodextrin in young adults and elderly.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

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
unknown

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 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

February 26, 2020

Last Update Submit

February 26, 2020

Conditions

Aspiration; LiquidsFastingPerioperative Pulmonary Aspiration

Outcome Measures

Primary Outcomes (1)

  • Antral Volume change

    Antral volume in cm² assessed by ultrasound in semirecumbent position.

    Just before and 5, 30, 60, 90 and 120 minutes after drinking the study solution (repeated measures)

Study Arms (2)

Adults

ACTIVE COMPARATOR

Adults \< 60 years-old maltodextrin solution 450ml

Dietary Supplement: maltodextrin

Elders

ACTIVE COMPARATOR

Elders 65 or more years-old maltodextrin solution 450ml

Dietary Supplement: maltodextrin

Interventions

maltodextrinDIETARY_SUPPLEMENT

maltodextrin solution 450ml

AdultsElders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I or II;
  • No known risk factor for slow or fast gastric emptying.

You may not qualify if:

  • Vomiting the study solution before completion.
  • Wrong timing of assessment.
  • Protocol violation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Forças armadas

Brasília, Federal District, 700000000, Brazil

Location

MeSH Terms

Conditions

Fasting

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Gabriel MN Guimaraes, MSc

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 26, 2020

First Posted

February 28, 2020

Study Start

January 1, 2020

Primary Completion

April 1, 2020

Study Completion

July 1, 2020

Last Updated

February 28, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Plan to Share in Online Data Sharing Platform.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
We will put SAP and Analytic code in RPubs for as long as RPubs exists. Study protocol and ICF will be published in ClinicalTrials
Access Criteria
Open

Locations

BR(1)