Gastric Emptying of Maltodextrin Solution in Elderly and... | NCT04288466

Studies
Gastric Emptying of Maltodextrin Solution in Elderly and in Adults

NCT04288466

Sponsor

Brasilia University Hospital

Status

Unknown status

Last Update Posted

Feb 28, 2020Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Aspiration; Liquids
Fasting
Perioperative Pulmonary Aspiration

Interventions

maltodextrin

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Apr 1, 2020Estimated

Completion Date

Jul 1, 2020Estimated

First Submitted Date

Feb 26, 2020

First Submission Date that Met QC Criteria

Feb 26, 2020

First Posted Date

Feb 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2020

Last Update Posted Date

Feb 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gabriel Magalhaes Nunes Guimaraes, Clinical Professor, Brasilia University HospitalPrincipal Investigator

Lead Sponsor

Brasilia University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
maltodextrin	Dietary Supplement	maltodextrin solution 450ml	Adults Elders

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabriel MN Guimaraes, MSc	Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital das Forças armadas		Brasília	Federal District	700000000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Plan to Share in Online Data Sharing Platform.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005215	Fasting

Ancestor Terms

ID	Term
D005247	Feeding Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C008315	maltodextrin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided