Aspiration; LiquidsGEMANCT04288466
Gastric Emptying of Maltodextrin Solution in Elderly and in Adults
A study testing maltodextrin in people with Aspiration; Liquids and Fasting, run by Brasilia University Hospital at 1 site in Brazil.
Trial summary
Gastric volume will be measured before, 5, 30, 60, 90 and 120 min after drinking 450ml of maltodextrin in young adults and elderly. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aspiration; Liquids, Fasting, Perioperative Pulmonary Aspiration
- What is being tested?
- maltodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2020to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA physical status I or II;
- No known risk factor for slow or fast gastric emptying.
Who cannot join
- Vomiting the study solution before completion.
- Wrong timing of assessment.
- Protocol violation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastric Emptying of Maltodextrin Solution in Elderly and in Adults: Clinical Trial
Gastric volume will be measured before, 5, 30, 60, 90 and 120 min after drinking 450ml of maltodextrin in young adults and elderly.
Read the 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.
- Being tested
- maltodextrin
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maltodextrinDietary supplement
maltodextrin solution 450ml
| Study group | Role | What they receive |
|---|---|---|
| Adults | Active comparator | Adults < 60 years-old maltodextrin solution 450ml Receives: Dietary Supplement: maltodextrin |
| Elders | Active comparator | Elders 65 or more years-old maltodextrin solution 450ml Receives: Dietary Supplement: maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antral Volume change
Antral volume in cm² assessed by ultrasound in semirecumbent position.
Measured: Just before and 5, 30, 60, 90 and 120 minutes after drinking the study solution (repeated measures)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Jan 2020
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration; LiquidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brasilia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital
- Investigators
- Gabriel MN Guimaraes, MSc, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288466
- Sponsor's protocol ID
- tccandre2020
- Acronym
- GEMA
- Status last verified
- Feb 2020
- First submitted
- 26 Feb 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to Share in Online Data Sharing Platform.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying of Maltodextrin Solution in Elderly and in Adults: Clinical Trial
- ClinicalTrials.gov ID
- NCT04288466
- Acronym / sponsor ID
- GEMA / tccandre2020
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brasilia University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults | Active comparator | Dietary Supplement: maltodextrinAdults < 60 years-old maltodextrin solution 450ml |
| Elders | Active comparator | Dietary Supplement: maltodextrinElders 65 or more years-old maltodextrin solution 450ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status I or II;
- No known risk factor for slow or fast gastric emptying.
Key exclusion criteria (3 listed)
- Vomiting the study solution before completion.
- Wrong timing of assessment.
- Protocol violation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maltodextrinmaltodextrin solution 450ml | Dietary supplement | Adults, Elders |
Primary outcome
Antral Volume change
Time frame: Just before and 5, 30, 60, 90 and 120 minutes after drinking the study solution (repeated measures)
Antral volume in cm² assessed by ultrasound in semirecumbent position.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: Yes. Plan to Share in Online Data Sharing Platform.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel MN Guimaraes, MSc principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maltodextrin in people with Aspiration; Liquids and Fasting, run by Brasilia University Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antral Volume change (time frame: Just before and 5, 30, 60, 90 and 120 minutes after drinking the study solution (repeated measures)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.