Gastric UltrasonographyNCT07555080
Comparison of Gastric Volume Changes After Ventilation With Endotracheal Tube, First-Generation Supraglottic Airway, and Second-Generation Supraglottic Airway in Pediatric Patients
An observational study of Gastric Ultrasonography and Supraglottic Airways, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the gastric volumes of pediatric patients undergoing positive-pressure ventilation with different airway management techniques. Gastric ultrasound is a non-invasive bedside tool with high sensitivity and specificity for determining the nature and amount of gastric content. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Gastric Ultrasonography, Supraglottic Airways, Supraglottic Airway Use in Children
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to Sep 2026
- How long will I take part?
- 1 Day
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients (1-10 years) undergoing elective surgery
Who may be able to join
- 1-10 years of age
- Adherence to standard preoperative fasting guidelines
- Elective surgeries
- ASA I-III status
- Surgery time 30 min to 2 hours
Who cannot join
- Gastrointestinal tract surgeries
- Laparoscopic surgeries
- Emergency procedures
- Full stomach patients
- Lack of parental/guardian consent
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
Istanbul University
Istanbul
Meltem Savran Karadeniz, professor, 009005334845563, mskaradeniz@gmail.com
About this study
Official title: Comparison of Gastric Volume Changes Via Ultrasound After Ventilation With Endotracheal Tube, First-Generation Supraglottic Airway, and Second-Generation Supraglottic Airway in Pediatric Patients: A Prospective Observational Study
This study aims to compare the gastric volumes of pediatric patients undergoing positive-pressure ventilation with different airway management techniques. Gastric ultrasound is a non-invasive bedside tool with high sensitivity and specificity for determining the nature and amount of gastric content. In pediatric cases, maintaining a gastric volume below 1.25 mL/kg is associated with a lower risk of perioperative aspiration.
Although supraglottic airway devices (SADs) are commonly used as alternatives to endotracheal tubes, concerns regarding the potential for gastric insufflation and subsequent aspiration persist. Second-generation SADs were specifically designed with gastric drainage channels to mitigate the risk of regurgitation compared to first-generation devices.
The primary objective of this study is to determine whether there is a difference in gastric volumes, as measured by ultrasound, among three groups of pediatric patients: those managed with endotracheal tubes, first-generation SADs, and second-generation SADs. By comparing these measurements post-ventilation, the investigators aim to evaluate the impact of the airway device choice on gastric volume under clinical conditions.
Read the detailed description
All participants will receive a standard preoperative intravenous (IV) dose of 0.1 mg/kg midazolam in the preparation room. Upon arrival at the operating room, routine monitoring will be established for all patients, including electrocardiography (ECG), non-invasive blood pressure (NIBP), and peripheral oxygen saturation (SpO2). Before the induction of anesthesia (T0), the gastric antral area will be evaluated using ultrasound in the right lateral decubitus (RLD) position. A high-frequency linear probe will be placed sagittally in the epigastric region to visualize the stomach antrum, located posterior to the left lobe of the liver and anterior to the abdominal aorta. The largest and smallest diameters (d1 and d2) of the elliptical antrum will be measured. The Antral Cross-Sectional Area (ACSA) will be calculated using the formula: ACSA = d1*d2*pi/4. Gastric volume will then be derived using the validated pediatric formula: [0.035*ACSA (mm2) + 0.127*age (months) - 7.8] / body weight (kg). Standard general anesthesia induction will be performed using sevoflurane and oxygen inhalation, 1 mcg/kg IV fentanyl, and 0.5 mg/kg IV rocuronium. Following induction, patients will be managed with either endotracheal intubation or a supraglottic airway device (SAD). The choice of airway management will follow routine clinical practice. SAD size and cuff inflation volume will adhere to the manufacturer's recommendations. Any volume leakage during ventilation will be recorded as a percentage. Anesthesia maintenance will be provided with 1 MAC sevoflurane in an oxygen/air mixture. The gastric antral area will be re-evaluated via ultrasound in the RLD position at two additional time points: T1: Immediately after the airway device is secured and ventilation is established, before the start of surgery. T2: At the end of the surgical procedure, before the patient emerges from anesthesia. All relevant clinical data will be recorded in the patient follow-up form, including age, gender, height, weight, duration of surgery, vital signs, type of airway device used, perioperative airway pressures, and any observed complications. Following the final measurement, patients will be emerged from anesthesia and transferred to the postoperative recovery room according to standard protocols.
- Conditions
- Gastric Ultrasonography, Supraglottic Airways, Supraglottic Airway Use in Children, Gastric Volume, Gastric Insufflation, Airway Complications
- Keywords
- gastric ultrasonography, airway management
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 |
|---|---|---|
| Endotracheal intubation tube | The patients who ventilated by endotracheal tube | |
| First-generation supraglottic airway | Patients ventilated via a first-generation supraglottic airway | |
| Second-generation supraglottic airway | Patients ventilated via a second-generation supraglottic airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of gastric volume changes smong study groups
The primary outcome is to compare the change in gastric volume calculated via ultrasound at T0 (before induction), T1 (after the airway secured), and T2 (end of the operation) among the three groups (Endotracheal tube, first-generation SAD, and second-generation SAD). This will determine whether the choice of airway device leads to a difference in gastric volume during the perioperative period.
Measured: up to 2 hours
Secondary outcomes (8)
Correlation between duration of surgery and change in gastric volume
Total duration of the surgical procedure and the change in gastric volume
Measured: 30 minutes to 2 hours
Antral cross sectional area changes
Meauserement of antral cross sectional area at T0, T1 and T2 on lateral decubitis position
Measured: up to 2 hours
Air leakege
Air leakage percentage with different airway devices
Measured: up to 2 hours
Airway pressures
Peak airway pressures during surgery duration
Measured: up to 2 hours
SpO2
Pulse oximeter
Measured: up to 2 hours
Heart rate
ECG monitoring
Measured: up to 2 hours
Mean arteryal pressure
Non-invasive blood pressure measurement
Measured: up to 2 hours
Airway complications
Perioperative airway complications such as bronchospasm, laryngospasm etc. will be noted
Measured: up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start15 Jun 2026
- Primary completion20 Aug 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric UltrasonographyStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- 250 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
- Investigators
- Meltem Savran Karadeniz, Principal investigator, Istanbul University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555080
- Sponsor's protocol ID
- 2025/437
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pan S, Lin C, Tsui BCH. Neonatal and paediatric point-of-care ultrasound review. Australas J Ultrasound Med. 2022 Oct 13;26(1):46-58. doi: 10.1002/ajum.12322. eCollection 2023 Feb.
PubMed 36960139Theiler L, Gutzmann M, Kleine-Brueggeney M, Urwyler N, Kaempfen B, Greif R. i-gel supraglottic airway in clinical practice: a prospective observational multicentre study. Br J Anaesth. 2012 Dec;109(6):990-5. doi: 10.1093/bja/aes309. Epub 2012 Sep 6.
PubMed 22956643Alakkad H, Kruisselbrink R, Chin KJ, Niazi AU, Abbas S, Chan VW, Perlas A. Point-of-care ultrasound defines gastric content and changes the anesthetic management of elective surgical patients who have not followed fasting instructions: a prospective case series. Can J Anaesth. 2015 Nov;62(11):1188-95. doi: 10.1007/s12630-015-0449-1. Epub 2015 Aug 4.
PubMed 26239668
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gastric Volume Changes Via Ultrasound After Ventilation With Endotracheal Tube, First-Generation Supraglottic Airway, and Second-Generation Supraglottic Airway in Pediatric Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07555080
- Acronym / sponsor ID
- 2025/437
- Conditions
- Gastric Ultrasonography, Supraglottic Airways, Supraglottic Airway Use in Children, Gastric Volume, Gastric Insufflation, Airway Complications
- Keywords
- gastric ultrasonography, airway management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 28 Apr 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.
This study aims to compare the gastric volumes of pediatric patients undergoing positive-pressure ventilation with different airway management techniques. Gastric ultrasound is a non-invasive bedside tool with high sensitivity and specificity for determining the nature and amount of gastric content. In pediatric cases, maintaining a gastric volume below 1.25 mL/kg is associated with a lower risk of perioperative aspiration.
Although supraglottic airway devices (SADs) are commonly used as alternatives to endotracheal tubes, concerns regarding the potential for gastric insufflation and subsequent aspiration persist. Second-generation SADs were specifically designed with gastric drainage channels to mitigate the risk of regurgitation compared to first-generation devices.
The primary objective of this study is to determine whether there is a difference in gastric volumes, as measured by ultrasound, among three groups of pediatric patients: those managed with endotracheal tubes, first-generation SADs, and second-generation SADs. By comparing these measurements post-ventilation, the investigators aim to evaluate the impact of the airway device choice on gastric volume under clinical conditions.
Detailed description
All participants will receive a standard preoperative intravenous (IV) dose of 0.1 mg/kg midazolam in the preparation room. Upon arrival at the operating room, routine monitoring will be established for all patients, including electrocardiography (ECG), non-invasive blood pressure (NIBP), and peripheral oxygen saturation (SpO2). Before the induction of anesthesia (T0), the gastric antral area will be evaluated using ultrasound in the right lateral decubitus (RLD) position. A high-frequency linear probe will be placed sagittally in the epigastric region to visualize the stomach antrum, located posterior to the left lobe of the liver and anterior to the abdominal aorta. The largest and smallest diameters (d1 and d2) of the elliptical antrum will be measured. The Antral Cross-Sectional Area (ACSA) will be calculated using the formula: ACSA = d1*d2*pi/4. Gastric volume will then be derived using the validated pediatric formula: [0.035*ACSA (mm2) + 0.127*age (months) - 7.8] / body weight (kg). Standard general anesthesia induction will be performed using sevoflurane and oxygen inhalation, 1 mcg/kg IV fentanyl, and 0.5 mg/kg IV rocuronium. Following induction, patients will be managed with either endotracheal intubation or a supraglottic airway device (SAD). The choice of airway management will follow routine clinical practice. SAD size and cuff inflation volume will adhere to the manufacturer's recommendations. Any volume leakage during ventilation will be recorded as a percentage. Anesthesia maintenance will be provided with 1 MAC sevoflurane in an oxygen/air mixture. The gastric antral area will be re-evaluated via ultrasound in the RLD position at two additional time points: T1: Immediately after the airway device is secured and ventilation is established, before the start of surgery. T2: At the end of the surgical procedure, before the patient emerges from anesthesia. All relevant clinical data will be recorded in the patient follow-up form, including age, gender, height, weight, duration of surgery, vital signs, type of airway device used, perioperative airway pressures, and any observed complications. Following the final measurement, patients will be emerged from anesthesia and transferred to the postoperative recovery room according to standard protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endotracheal intubation tube | – | –The patients who ventilated by endotracheal tube |
| First-generation supraglottic airway | – | –Patients ventilated via a first-generation supraglottic airway |
| Second-generation supraglottic airway | – | –Patients ventilated via a second-generation supraglottic airway |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients (1-10 years) undergoing elective surgery
Key inclusion criteria (5 listed)
- 1-10 years of age
- Adherence to standard preoperative fasting guidelines
- Elective surgeries
- ASA I-III status
- Surgery time 30 min to 2 hours
Key exclusion criteria (5 listed)
- Gastrointestinal tract surgeries
- Laparoscopic surgeries
- Emergency procedures
- Full stomach patients
- Lack of parental/guardian consent
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
Comparison of gastric volume changes smong study groups
Time frame: up to 2 hours
The primary outcome is to compare the change in gastric volume calculated via ultrasound at T0 (before induction), T1 (after the airway secured), and T2 (end of the operation) among the three groups (Endotracheal tube, first-generation SAD, and second-generation SAD). This will determine whether the choice of airway device leads to a difference in gastric volume during the perioperative period.
8 secondary outcomes
Correlation between duration of surgery and change in gastric volume
Time frame: 30 minutes to 2 hours
Antral cross sectional area changes
Time frame: up to 2 hours
Air leakege
Time frame: up to 2 hours
Airway pressures
Time frame: up to 2 hours
SpO2
Time frame: up to 2 hours
Heart rate
Time frame: up to 2 hours
Mean arteryal pressure
Time frame: up to 2 hours
Airway complications
Time frame: up to 3 hours
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 17 Sep 2026.
- Background: PubMed 36960139Pan S, Lin C, Tsui BCH. Neonatal and paediatric point-of-care ultrasound review. Australas J Ultrasound Med. 2022 Oct 13;26(1):46-58. doi: 10.1002/ajum.12322. eCollection 2023 Feb.
- Background: PubMed 22956643Theiler L, Gutzmann M, Kleine-Brueggeney M, Urwyler N, Kaempfen B, Greif R. i-gel supraglottic airway in clinical practice: a prospective observational multicentre study. Br J Anaesth. 2012 Dec;109(6):990-5. doi: 10.1093/bja/aes309. Epub 2012 Sep 6.
- Background: PubMed 26239668Alakkad H, Kruisselbrink R, Chin KJ, Niazi AU, Abbas S, Chan VW, Perlas A. Point-of-care ultrasound defines gastric content and changes the anesthetic management of elective surgical patients who have not followed fasting instructions: a prospective case series. Can J Anaesth. 2015 Nov;62(11):1188-95. doi: 10.1007/s12630-015-0449-1. Epub 2015 Aug 4.
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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.
Meltem Savran Karadeniz principal investigator
Istanbul University Faculty of Medicine
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 Ultrasonography and Supraglottic Airways, run by Istanbul 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 5 inclusion and 5 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 17 Sep 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 Meltem Savran Karadeniz, Professor (+9005334845563, mskaradeniz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of gastric volume changes smong study groups (time frame: up to 2 hours). 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 NCT07555080, which also lists 3 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 17 Sep 2026.