FastingNCT04789785
Gastric Emptying Time After Turkish Breakfast
An observational study of Fasting, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- ultrasound
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2021to 20 Feb 2021
- Phase
- Observational
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: over 65 years of age Turkish volunteers without comorbity
Who may be able to join
- over 65 years of age who have not any comorbidities
Who cannot join
- gastrointestinal and functional disorders, previous oesophageal or upper abdomen surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa TREH
Istanbul, Gaziosmanpaşa, 34255
About this study
Official title: : Determining Gastric Emptying Time In Elderly Using Ultrasound Associated With Preoperative Fasting Time
DETERMINING GASTRIC EMPTYING TIME IN ELDERLY USING ULTRASOUND ASSOCIATED WITH PREOPERATIVE FASTING TIME
Background:
Read more
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.
Read the detailed description
Preoperative fasting has always been problematic in preoperative patients because of the pulmonary aspiration hazard and discomfort of prolonged fasting. Although stomach scintigraphy has been accepted as a gold standard for imaging method of evaluating gastric content; recently, ultrasound is being a simple, efficient, available and non invasive alternative. Preoperative fasting is especially difficult in elderly because of comorbidities, dehydration, drug therapies. Therefore, in this study gastric emptying time will be identified after a standard Turkish breakfast in over 65 years old Turkish population to clarify fasting time, measuring antral cross section area (CSA) by using non invasive ultrasound for the first time. Ultrasound assessments on volunteers will be made both in the supine position and right lateral decubitus (RLD) from the epigastric area by using a convex probe. After visualization of gastric antrum according to landmarks such as abdominal aorta, superior mesenteric artery and the left lobe of liver; antrum will measured in two sagittal planes: craniocaudal (CC) and anteroposterior(AP) diameters. Gastric emptying time will be identify by real time usg done by 1 hour intervals.This is the first study with ultrasound evaluation of gastric emptying time in Turkish population after a traditional Turkish breakfast.
- Conditions
- Fasting
- Being tested
- ultrasound
- Keywords
- gastric content, gastric ultrasonography, preoperative fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
observation with usg
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluating gastric emptying time assosiated with preoperative fasting
By measuring gastric cross section area using ultrasound to find the emptying time about 6 hours
Measured: base and real time measurements for 6 hours by 1 hour intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start5 Jan 2021
- Primary completion20 Feb 2021
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FastingStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SİBEL BEKTAŞ, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789785
- Sponsor's protocol ID
- 182
- Status last verified
- Mar 2021
- First submitted
- 22 Feb 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publishing in a journal
Publications
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.
PubMed 26195094Bolondi 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.
PubMed 3896910
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- : Determining Gastric Emptying Time In Elderly Using Ultrasound Associated With Preoperative Fasting Time
- ClinicalTrials.gov ID
- NCT04789785
- Acronym / sponsor ID
- 182
- Conditions
- Fasting
- Keywords
- gastric content, gastric ultrasonography, preoperative fasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 10 Mar 2021 (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.
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.
Detailed description
Preoperative fasting has always been problematic in preoperative patients because of the pulmonary aspiration hazard and discomfort of prolonged fasting. Although stomach scintigraphy has been accepted as a gold standard for imaging method of evaluating gastric content; recently, ultrasound is being a simple, efficient, available and non invasive alternative. Preoperative fasting is especially difficult in elderly because of comorbidities, dehydration, drug therapies. Therefore, in this study gastric emptying time will be identified after a standard Turkish breakfast in over 65 years old Turkish population to clarify fasting time, measuring antral cross section area (CSA) by using non invasive ultrasound for the first time. Ultrasound assessments on volunteers will be made both in the supine position and right lateral decubitus (RLD) from the epigastric area by using a convex probe. After visualization of gastric antrum according to landmarks such as abdominal aorta, superior mesenteric artery and the left lobe of liver; antrum will measured in two sagittal planes: craniocaudal (CC) and anteroposterior(AP) diameters. Gastric emptying time will be identify by real time usg done by 1 hour intervals.This is the first study with ultrasound evaluation of gastric emptying time in Turkish population after a traditional Turkish breakfast.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- over 65 years of age Turkish volunteers without comorbity
Key inclusion criteria (1 listed)
- over 65 years of age who have not any comorbidities
Key exclusion criteria (1 listed)
- gastrointestinal and functional disorders, previous oesophageal or upper abdomen surgery.
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 |
|---|---|---|
| ultrasoundobservation with usg | Diagnostic test | – |
Primary outcome
evaluating gastric emptying time assosiated with preoperative fasting
Time frame: base and real time measurements for 6 hours by 1 hour intervals
By measuring gastric cross section area using ultrasound to find the emptying time about 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: PubMed 26195094Soenen 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.
- Background: PubMed 3896910Bolondi 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.
- Individual participant dataSharing planned: Undecided. Publishing in a journal
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Mar 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
evaluating gastric emptying time assosiated with preoperative fasting (time frame: base and real time measurements for 6 hours by 1 hour intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04789785, which also lists 2 linked publications.
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 10 Mar 2021.