Gastric EmptyingNCT06195488
Gastric Ultrasound in Diabetic Patients
An observational study of Gastric Emptying and Diabetes, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The American Society of Anesthesiologists (ASA) does not specify a fasting period for patients with certain comorbidities, such as diabetes, for elective surgery, and does not make a separate recommendation for surgery. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Emptying, Diabetes, Ultrasound
- What is being tested?
- Gastric ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2022to 1 Jan 2025
- How long will I take part?
- 1 Day
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diabetic and non-diabetic patients aged 40-65 years undergoing ASA I-III elective surgery
Who may be able to join
- Written informed consent obtained 40-65 BMI<40 ASA I-III Fasting for at least 8 hours Elective surgery
Who cannot join
- Pregnancy Upper gastrointestinal malignancy Large Hiatal Hernia Kidney failure Liver failure Opioid use Use of drugs affecting motility Previous upper abdominal surgery BMI ≥40 kg/m2 Emergency surgery Diabetic ketoacidosis Sepsis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University Medicine Faculty
Zonguldak, Kozlu, 67600
About this study
Official title: Preoperative Evaluation of Gastric Contents in Diabetic Patients With Gastric Ultrasound
The American Society of Anesthesiologists (ASA) does not specify a fasting period for patients with certain comorbidities, such as diabetes, for elective surgery, and does not make a separate recommendation for surgery.
The European Society of Anesthesiology (ESA) guidelines do not differentiate between diabetic patients and normal patients. Aspiration of gastric contents is a common cause of perioperative morbidity and mortality.
Read more
Aspiration can cause hypoxia, bronchospasm, pneumonia, acute respiratory distress syndrome and death.
The presence of food or fluid in the stomach before induction of anesthesia is one of the greatest risk factors for perioperative pulmonary aspiration. Sedation and general anesthesia suppress or inhibit physiologic mechanisms (tone of the lower esophageal sphincter and upper airway reflexes) that protect against aspiration.
Because restriction of fluid and food intake before general anesthesia is vital for patient safety, Anesthesiology societies have developed guidelines for preoperative fasting.
Current ASA guidelines recommend at least 2 hours fasting for clear liquids, 6 hours fasting after a light meal (toast and clear liquids) and 8 hours fasting after a high calorie or fat meal. The information obtained from gastric ultrasound allows anesthesiologists to determine the optimal timing of procedures, type of anesthesia and airway management technique.
- Conditions
- Gastric Emptying, Diabetes, Ultrasound
- Being tested
- Gastric ultrasound
- Keywords
- fasting, gastric ultrasound, preoperative fasting, diabetes
- Medical subject headings
- Diabetes Mellitus, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasoundProcedure or surgery
performing gastric ultrasound to determine gastric contents
| Study group | Role | What they receive |
|---|---|---|
| Group D | Group Diabetic Receives: Procedure: Gastric ultrasound | |
| Group Control | Non-diabetic patients Receives: Procedure: Gastric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine stomach fullness
To evaluate residual gastric volume in diabetic patients fasting for elective surgery
Measured: baseline (before intubation)
Secondary outcomes (1)
Incidence of risk factors
Investigating risk factors for a full stomach in diabetic patients
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start15 Oct 2022
- Primary completion31 Oct 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric EmptyingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengü Gülhan Köksal, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195488
- Sponsor's protocol ID
- 2022/17-1
- Status last verified
- May 2025
- First submitted
- 24 Nov 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bayram MG, Incegul BGK, Baytar MS, Baytar C, Bollucuoglu K, Okyay RD, Seker DF, Piskin O, Ayoglu H. Preoperative ultrasound assessment of gastric volume in diabetic patients scheduled for elective surgery: a prospective, observational, comparative cohort study. BMC Anesthesiol. 2026 Jul 29;26(1):636. doi: 10.1186/s12871-026-04132-z.
PubMed 42928115
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Evaluation of Gastric Contents in Diabetic Patients With Gastric Ultrasound
- ClinicalTrials.gov ID
- NCT06195488
- Acronym / sponsor ID
- 2022/17-1
- Conditions
- Gastric Emptying, Diabetes, Ultrasound
- Keywords
- fasting, gastric ultrasound, preoperative fasting, diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 8 Jan 2024 (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.
The American Society of Anesthesiologists (ASA) does not specify a fasting period for patients with certain comorbidities, such as diabetes, for elective surgery, and does not make a separate recommendation for surgery.
The European Society of Anesthesiology (ESA) guidelines do not differentiate between diabetic patients and normal patients. Aspiration of gastric contents is a common cause of perioperative morbidity and mortality.
Aspiration can cause hypoxia, bronchospasm, pneumonia, acute respiratory distress syndrome and death.
The presence of food or fluid in the stomach before induction of anesthesia is one of the greatest risk factors for perioperative pulmonary aspiration. Sedation and general anesthesia suppress or inhibit physiologic mechanisms (tone of the lower esophageal sphincter and upper airway reflexes) that protect against aspiration.
Because restriction of fluid and food intake before general anesthesia is vital for patient safety, Anesthesiology societies have developed guidelines for preoperative fasting.
Current ASA guidelines recommend at least 2 hours fasting for clear liquids, 6 hours fasting after a light meal (toast and clear liquids) and 8 hours fasting after a high calorie or fat meal. The information obtained from gastric ultrasound allows anesthesiologists to determine the optimal timing of procedures, type of anesthesia and airway management technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | – | Procedure: Gastric ultrasoundGroup Diabetic |
| Group Control | – | Procedure: Gastric ultrasoundNon-diabetic patients |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic and non-diabetic patients aged 40-65 years undergoing ASA I-III elective surgery
Key inclusion criteria (1 listed)
- Written informed consent obtained 40-65 BMI<40 ASA I-III Fasting for at least 8 hours Elective surgery
Key exclusion criteria (1 listed)
- Pregnancy Upper gastrointestinal malignancy Large Hiatal Hernia Kidney failure Liver failure Opioid use Use of drugs affecting motility Previous upper abdominal surgery BMI ≥40 kg/m2 Emergency surgery Diabetic ketoacidosis Sepsis
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 |
|---|---|---|
| Gastric ultrasoundperforming gastric ultrasound to determine gastric contents | Procedure or surgery | Group Control, Group D |
Primary outcome
determine stomach fullness
Time frame: baseline (before intubation)
To evaluate residual gastric volume in diabetic patients fasting for elective surgery
1 secondary outcome
Incidence of risk factors
Time frame: during surgery
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 22 May 2025.
- Derived from this study: PubMed 42928115Bayram MG, Incegul BGK, Baytar MS, Baytar C, Bollucuoglu K, Okyay RD, Seker DF, Piskin O, Ayoglu H. Preoperative ultrasound assessment of gastric volume in diabetic patients scheduled for elective surgery: a prospective, observational, comparative cohort study. BMC Anesthesiol. 2026 Jul 29;26(1):636. doi: 10.1186/s12871-026-04132-z.
- Individual participant dataSharing planned: No
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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 Gastric Emptying and Diabetes, run by Zonguldak Bulent Ecevit University 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 22 May 2025. 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?
determine stomach fullness (time frame: baseline (before intubation)). 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 NCT06195488, which also lists 1 linked publication.
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 22 May 2025.