PreoperativeNCT07031414
Preoperative Residual Gastric Volume
An observational study of Preoperative and Gastric, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to assess the preoperative gastric residual volume in adult patients undergoing elective surgery. The main question it aims to answer is: Does gastric residual volume, content type, and aspiration risk differ between diabetic and non-diabetic patients with similar fasting… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Preoperative, Gastric, Residual Volume
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 15 Aug 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients aged 18 to 65 years, of both sexes, who are scheduled for elective surgery under general anesthesia. Participants will be classified into two groups: those with a documented history of diabetes mellitus (diabetic group) and those without (non-diabetic group). All patients will have American Society of Anesthesiologists (ASA) physical status I-III. The study will be conducted at Izmir City Hospital, and only patients who provide written informed consent will be included.
Who may be able to join
- Aged 18 to 65 years,
- American Society of Anesthesiologists (ASA) physical status I -III
- Scheduled for elective surgery under general anesthesia.
- Patients with a known history of diabetes mellitus will be included in the diabetic group.
Who cannot join
- Pregnant patients
- Patients with gastrointestinal obstructive diseases
- Patients with gastroesophageal reflux disease
- History of gastrointestinal surgery
- Emergency surgery cases
- Recent history of abdominal trauma
- Non-diabetic patients with autonomic or neurological disorders
- Patients with chronic kidney disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Izmir Faculty of Medicine, Izmir City Hospital
Izmir, 35150
About this study
Official title: Comparison of Ultrasonography-Guided Residual Gastric Volume Measurement Before Elective Surgery in Diabetic and Non-Diabetic Patients
The goal of this observational study is to assess the preoperative gastric residual volume in adult patients undergoing elective surgery. The main question it aims to answer is:
Does gastric residual volume, content type, and aspiration risk differ between diabetic and non-diabetic patients with similar fasting durations?
Participants undergoing elective surgery will receive bedside gastric ultrasound as part of their preoperative assessment. Ultrasound images will be used to estimate gastric volume and evaluate aspiration risk.
Read the detailed description
The goal of this observational study is to assess whether bedside gastric ultrasound can identify differences in residual gastric volume, content type, and aspiration risk in adult diabetic and non-diabetic patients (ages 18-65) undergoing elective surgery under general anesthesia.
The main questions it aims to answer are:
Do diabetic patients have higher residual gastric volume than non-diabetic patients despite similar fasting durations?
Does the type or amount of gastric content differ between the two groups, potentially increasing aspiration risk?
Researchers will compare diabetic and non-diabetic groups to see if diabetes is associated with delayed gastric emptying and increased aspiration risk.
Participants will:
Undergo bedside gastric ultrasound prior to anesthesia induction
Be scanned in semi-sitting and right lateral decubitus positions using a convex ultrasound probe
Have gastric antrum graded and volume calculated
Be evaluated for aspiration risk based on validated ultrasound criteria
- Conditions
- Preoperative, Gastric, Residual Volume
- Keywords
- Ultrasonography-Guided, Residual gastric volume, Diabetes mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Group - Patients with a diagnosis of diabetes mellitus Non-Diabetic Group - Patients witho | Diabetic Group Adult patients (aged 18-65) with a known diagnosis of diabetes mellitus who are scheduled for elective surgery under general anesthesia. These participants will undergo preoperative bedside gastric ultrasound to evaluate residual gastric volume, content type, and aspiration risk. Non-Diabetic Group Adult patients (aged 18-65) without diabetes mellitus, scheduled for elective surgery under general anesthesia. These participants will also undergo preoperative bedside gastric ultrasound for the same assessments as the diabetic group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual gastric volume (mL) measured by bedside ultrasound in diabetic vs. non-diabetic patients.
The main question of the study is whether gastric emptying is delayed in diabetic patients, resulting in a higher residual gastric volume.
Measured: Immediately before induction of anesthesia (preoperative period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start15 Mar 2025
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreoperativeStudies 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
- 400 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Derya Arslan Yurtlu, Izmir City Hospital
- Investigators
- Derya A. Yurtlu, M.D., Principal investigator, Izmir City Hospital, Izmir, TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031414
- Sponsor's protocol ID
- IZMIR CITY HOSPİTAL
- Other IDs
- IZMIR CITY HOSPİTAL
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The reason is that the local health authority (Provincial Health Directorate) did not grant permission for the sharing of individual participant-level data with external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasonography-Guided Residual Gastric Volume Measurement Before Elective Surgery in Diabetic and Non-Diabetic Patients
- ClinicalTrials.gov ID
- NCT07031414
- Acronym / sponsor ID
- IZMIR CITY HOSPİTAL
- Conditions
- Preoperative, Gastric, Residual Volume
- Keywords
- Ultrasonography-Guided, Residual gastric volume, Diabetes mellitus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Izmir City HospitalOther government
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 22 Jun 2025 (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 goal of this observational study is to assess the preoperative gastric residual volume in adult patients undergoing elective surgery. The main question it aims to answer is:
Does gastric residual volume, content type, and aspiration risk differ between diabetic and non-diabetic patients with similar fasting durations?
Participants undergoing elective surgery will receive bedside gastric ultrasound as part of their preoperative assessment. Ultrasound images will be used to estimate gastric volume and evaluate aspiration risk.
Detailed description
The goal of this observational study is to assess whether bedside gastric ultrasound can identify differences in residual gastric volume, content type, and aspiration risk in adult diabetic and non-diabetic patients (ages 18-65) undergoing elective surgery under general anesthesia.
The main questions it aims to answer are:
Do diabetic patients have higher residual gastric volume than non-diabetic patients despite similar fasting durations?
Does the type or amount of gastric content differ between the two groups, potentially increasing aspiration risk?
Researchers will compare diabetic and non-diabetic groups to see if diabetes is associated with delayed gastric emptying and increased aspiration risk.
Participants will:
Undergo bedside gastric ultrasound prior to anesthesia induction
Be scanned in semi-sitting and right lateral decubitus positions using a convex ultrasound probe
Have gastric antrum graded and volume calculated
Be evaluated for aspiration risk based on validated ultrasound criteria
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic Group - Patients with a diagnosis of diabetes mellitus Non-Diabetic Group - Patients witho | – | –Diabetic Group Adult patients (aged 18-65) with a known diagnosis of diabetes mellitus who are scheduled for elective surgery under general anesthesia. These participants will undergo preoperative bedside gastric ultrasound to evaluate residual gastric volume, content type, and aspiration risk. Non-Diabetic Group Adult patients (aged 18-65) without diabetes mellitus, scheduled for elective surgery under general anesthesia. These participants will also undergo preoperative bedside gastric ultrasound for the same assessments as the diabetic group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients aged 18 to 65 years, of both sexes, who are scheduled for elective surgery under general anesthesia. Participants will be classified into two groups: those with a documented history of diabetes mellitus (diabetic group) and those without (non-diabetic group). All patients will have American Society of Anesthesiologists (ASA) physical status I-III. The study will be conducted at Izmir City Hospital, and only patients who provide written informed consent will be included.
Key inclusion criteria (4 listed)
- Aged 18 to 65 years,
- American Society of Anesthesiologists (ASA) physical status I -III
- Scheduled for elective surgery under general anesthesia.
- Patients with a known history of diabetes mellitus will be included in the diabetic group.
Key exclusion criteria (8 listed)
- Pregnant patients
- Patients with gastrointestinal obstructive diseases
- Patients with gastroesophageal reflux disease
- History of gastrointestinal surgery
- Emergency surgery cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Residual gastric volume (mL) measured by bedside ultrasound in diabetic vs. non-diabetic patients.
Time frame: Immediately before induction of anesthesia (preoperative period)
The main question of the study is whether gastric emptying is delayed in diabetic patients, resulting in a higher residual gastric volume.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No. The reason is that the local health authority (Provincial Health Directorate) did not grant permission for the sharing of individual participant-level data with external researchers.
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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.
Derya A. Yurtlu, M.D. principal investigator
Izmir City Hospital, Izmir, TURKEY
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 Preoperative and Gastric, run by Izmir City 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Residual gastric volume (mL) measured by bedside ultrasound in diabetic vs. non-diabetic patients. (time frame: Immediately before induction of anesthesia (preoperative period)). 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 22 Jun 2025.