Nonoperating Room AnesthesiaNCT07581691
Evaluation of Preoperative Gastric Ultrasonography in Pediatric Patients in Terms of Patient Safety
An observational study of Nonoperating Room Anesthesia and Gastric Ultrasound, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Preoperative evaluation of stomach fullness with ultrasound in children who will undergo anesthesia outside the operating room Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Nonoperating Room Anesthesia, Gastric Ultrasound
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 30 Sep 2026
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: ASA I-II children aged 0-18 years who underwent non-operating room anesthesia
Who may be able to join
- Children between 0-18 years of age and ASA I-II patients will be included in the study.
Who cannot join
- Patients over 18 years of age,
- ASA-III and above patients,
- patients with gastrointestinal dysfunction,
- patients who cannot assume the lateral decubitus position for gastric -ultrasound measurements,
- those who have had previous lower esophageal or gastric surgery,
- those who do not comply with institutional fasting guidelines,
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- those with concomitant systemic diseases affecting gastric emptying,
- those with a high body mass index (BMI) > 40 kg/m2,
- those with gastroesophageal reflux or aspiration risk factors, and emergency cases with delayed gastric emptying despite appropriate fasting time will not be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University
Kayseri
Erciyes U
About this study
Official title: Evaluation of Preoperative Gastric Ultrasonography in Pediatric Patients in Terms of Patient Safety in Non-Operating Room Anesthesia Applications
Preoperative evaluation of stomach fullness with ultrasound in children who will undergo anesthesia outside the operating room
Read the detailed description
Determining the gastric contents and volume by preoperative gastric ultrasound in pediatric patients and defining its relationship with the risk of postoperative aspiration.
- Conditions
- Nonoperating Room Anesthesia, Gastric Ultrasound
- Keywords
- nonoperating room anesthesia, pediatric nonoperating room anesthesia, gastric ultrasound
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 |
|---|---|---|
| Group undergoing gastric ultrasound | Children between 0-18 years of age and ASA I-II patients will be included in the study. Stomach contents and volume will be determined with ultrasound and the postoperative effects of the values found will be examined. Gastric ultrasound will be performed before anesthesia induction, with children in the supine and lateral decubitus positions, using either a linear high-frequency or abdominal probe, depending on the age of the child, to obtain a sagittal section of the antrum in a plane that includes the left lobe of the liver and the aorta. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative assessment of residual gastric fluid volume
Grade 0: Defined as no contents visible in the antrum, the stomach is empty and the volume of the contents approaches zero.
Grade 1: Visible clear fluid with a fluid volume of <1.5 mL/kg. Grade 2: Defined as visible clear fluid with a fluid volume of >1.5 mL/kg in both the supine and lateral decubitus positions.
Measured: preoperative evaluation in the operating room
Secondary outcomes (2)
Gastric content volume
It will be calculated using a mathematical model validated in children aged 11 months to 18 years.
Volume(mL/kg) = [-7.8 + 0.035 × antral area measured in lateral decubitus position (mm2) + 0.127 × age (months)] / body weight (kg). The R² value for this model was 0.60.
Measured: preoperative evaluation in the operating room
Antral cross-sectional area
In both supine and lateral decubitus positions, between antral contractions, serosa to serosa, measuring the length diameter (D1) and the anteroposterior diameter (D2); Antral area = (π × D1 × D2) / 4 will be measured using the formula.
Measured: preoperative evaluation in the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start15 Nov 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonoperating Room AnesthesiaStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem ÖZ GERGİN, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581691
- Sponsor's protocol ID
- 2024/163
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Preoperative Gastric Ultrasonography in Pediatric Patients in Terms of Patient Safety in Non-Operating Room Anesthesia Applications
- ClinicalTrials.gov ID
- NCT07581691
- Acronym / sponsor ID
- 2024/163
- Conditions
- Nonoperating Room Anesthesia, Gastric Ultrasound
- Keywords
- nonoperating room anesthesia, pediatric nonoperating room anesthesia, gastric ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 12 May 2026 (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.
Preoperative evaluation of stomach fullness with ultrasound in children who will undergo anesthesia outside the operating room
Detailed description
Determining the gastric contents and volume by preoperative gastric ultrasound in pediatric patients and defining its relationship with the risk of postoperative aspiration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group undergoing gastric ultrasound | – | –Children between 0-18 years of age and ASA I-II patients will be included in the study. Stomach contents and volume will be determined with ultrasound and the postoperative effects of the values found will be examined. Gastric ultrasound will be performed before anesthesia induction, with children in the supine and lateral decubitus positions, using either a linear high-frequency or abdominal probe, depending on the age of the child, to obtain a sagittal section of the antrum in a plane that includes the left lobe of the liver and the aorta. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- ASA I-II children aged 0-18 years who underwent non-operating room anesthesia
Key inclusion criteria (1 listed)
- Children between 0-18 years of age and ASA I-II patients will be included in the study.
Key exclusion criteria (9 listed)
- Patients over 18 years of age,
- ASA-III and above patients,
- patients with gastrointestinal dysfunction,
- patients who cannot assume the lateral decubitus position for gastric -ultrasound measurements,
- those who have had previous lower esophageal or gastric surgery,
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
Qualitative assessment of residual gastric fluid volume
Time frame: preoperative evaluation in the operating room
Grade 0: Defined as no contents visible in the antrum, the stomach is empty and the volume of the contents approaches zero. Grade 1: Visible clear fluid with a fluid volume of <1.5 mL/kg. Grade 2: Defined as visible clear fluid with a fluid volume of >1.5 mL/kg in both the supine and lateral decubitus positions.
2 secondary outcomes
Gastric content volume
Time frame: preoperative evaluation in the operating room
Antral cross-sectional area
Time frame: preoperative evaluation in the operating room
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 12 May 2026.
- Individual participant dataSharing planned: No
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.
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 Nonoperating Room Anesthesia and Gastric Ultrasound, run by TC Erciyes 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 9 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: looking for participants now, as of the sponsor's last update on 12 May 2026. 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?
Contact Özlem OZ GERGIN, MD (09005332466396, oozgergin@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative assessment of residual gastric fluid volume (time frame: preoperative evaluation in the operating room). 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 12 May 2026.