PediatricsNCT06426394
Effect of Positive End-expiratory Pressure on Gastic Residual Volume
An observational study of Pediatrics and Fasting Period, run by Duygu Akyol at 1 site in Turkey (Türkiye).
Trial summary
This study was designed as a prospective observational study. Read more about this study
- Who is it for?
- Ages 1 year to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatrics, Fasting Period
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 May 2024to 31 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 1 year to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 90 patients were planned for this study.
Who may be able to join
- Pediatric patients who will undergo elective outpatient minor surgery (lower abdominal and urogenital)
- 1-11 years old
- American Society of Anesthesiology (ASA) classification 1-2 patient groups
- Patients who are fully hungry and whose fasting period is appropriate for their age and diet.
Who cannot join
- Patients whose fasting period is not appropriate
- Acute abdominal and emergency surgeries
- ASA 3-4 patient group
- Patients with diseases or medication use that will affect gastric emptying time
- Previous nasogastric tube placement and re-operation • Patients with known difficult airway or failure to fit the laryngeal mask
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of End-expiratory Positive Pressure on Gastric Residual Volume in Elective Pediatric Outpatient Surgery Where Laryngeal Mask is Applied
This study was designed as a prospective observational study.
Read the detailed description
In this study, it was planned to evaluate the effect of positive end-expiratory pressure on gastric residual volume in patients who will undergo outpatient pediatric surgery with laryngeal mask application on the specified dates. Patients aged 1-11 years, ASA I-II and undergoing outpatient lower abdominal and genitourinary surgery were included in the study. Since the use of positive end-expiratory pressure varies in our clinic depending on the anesthesiologist preference, the effect of this application on gastric volume will also be evaluated primarily by recording images with gastric ultrasonography at certain perioperative time periods. Secondarily, the effect of this positive end-expiratory pressure on mechanical ventilator parameters and airway pressures will be evaluated.
- Conditions
- Pediatrics, Fasting Period
- Keywords
- Gastric ultrasonography, gastric residual volume, pediatric outpatient surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric residual volume
The primary purpose of this study is to measure gastric residual volume with peroperative gastric ultrasonography measurements. Gastric residual volume will be calculated according to gastric ultrasonography measurements.
Measured: preoperatively, intraoperatively after laryngeal mask placement, before laryngeal mask removal at the end of surgery
Secondary outcomes (1)
Airway pressures
The secondary aim of this study was to evaluate the effect of positive end-expiratory pressures on airway pressures
Measured: intraoperative process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start17 May 2024
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PediatricsStudies 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
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Duygu Akyol
- Sponsor type
- Other government
- Collaborators
- Başakşehir Çam & Sakura City Hospital
- Responsible party
- Sponsor-investigator, Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426394
- Sponsor's protocol ID
- 2023-541
- Status last verified
- Sep 2024
- First submitted
- 14 May 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gunasekaran A, Govindaraj K, Gupta SL, Vinayagam S, Mishra SK. Comparison of Gastric Insufflation Volume Between Ambu AuraGain and ProSeal Laryngeal Mask Airway Using Ultrasonography in Patients Undergoing General Anesthesia: A Randomized Controlled Trial. Cureus. 2022 Aug 11;14(8):e27888. doi: 10.7759/cureus.27888. eCollection 2022 Aug.
PubMed 36110490Sharma G, Jacob R, Mahankali S, Ravindra MN. Preoperative assessment of gastric contents and volume using bedside ultrasound in adult patients: A prospective, observational, correlation study. Indian J Anaesth. 2018 Oct;62(10):753-758. doi: 10.4103/ija.IJA_147_18.
PubMed 30443057Beck CE, Rudolp D, Becke-Jakob K, Schindler E, Etspuler A, Trapp A, Fink G, Muller-Lobeck L, Roher K, Genahr A, Eich C, Sumpelmann R. Real fasting times and incidence of pulmonary aspiration in children: Results of a German prospective multicenter observational study. Paediatr Anaesth. 2019 Oct;29(10):1040-1045. doi: 10.1111/pan.13725. Epub 2019 Sep 4.
PubMed 31435997Fiedler MO, Schatzle E, Contzen M, Gernoth C, Weiss C, Walter T, Viergutz T, Kalenka A. Evaluation of Different Positive End-Expiratory Pressures Using Supreme Airway Laryngeal Mask during Minor Surgical Procedures in Children. Medicina (Kaunas). 2020 Oct 21;56(10):551. doi: 10.3390/medicina56100551.
PubMed 33096743
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of End-expiratory Positive Pressure on Gastric Residual Volume in Elective Pediatric Outpatient Surgery Where Laryngeal Mask is Applied
- ClinicalTrials.gov ID
- NCT06426394
- Acronym / sponsor ID
- 2023-541
- Conditions
- Pediatrics, Fasting Period
- Keywords
- Gastric ultrasonography, gastric residual volume, pediatric outpatient surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Duygu AkyolOther government
- Collaborators
- Başakşehir Çam & Sakura City Hospital
- Study start
- 17 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 23 May 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.
This study was designed as a prospective observational study.
Detailed description
In this study, it was planned to evaluate the effect of positive end-expiratory pressure on gastric residual volume in patients who will undergo outpatient pediatric surgery with laryngeal mask application on the specified dates. Patients aged 1-11 years, ASA I-II and undergoing outpatient lower abdominal and genitourinary surgery were included in the study. Since the use of positive end-expiratory pressure varies in our clinic depending on the anesthesiologist preference, the effect of this application on gastric volume will also be evaluated primarily by recording images with gastric ultrasonography at certain perioperative time periods. Secondarily, the effect of this positive end-expiratory pressure on mechanical ventilator parameters and airway pressures will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 1 year to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 90 patients were planned for this study.
Key inclusion criteria (4 listed)
- Pediatric patients who will undergo elective outpatient minor surgery (lower abdominal and urogenital)
- 1-11 years old
- American Society of Anesthesiology (ASA) classification 1-2 patient groups
- Patients who are fully hungry and whose fasting period is appropriate for their age and diet.
Key exclusion criteria (5 listed)
- Patients whose fasting period is not appropriate
- Acute abdominal and emergency surgeries
- ASA 3-4 patient group
- Patients with diseases or medication use that will affect gastric emptying time
- Previous nasogastric tube placement and re-operation • Patients with known difficult airway or failure to fit the laryngeal mask
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
Gastric residual volume
Time frame: preoperatively, intraoperatively after laryngeal mask placement, before laryngeal mask removal at the end of surgery
The primary purpose of this study is to measure gastric residual volume with peroperative gastric ultrasonography measurements. Gastric residual volume will be calculated according to gastric ultrasonography measurements.
1 secondary outcome
Airway pressures
Time frame: intraoperative process
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 19 Sep 2025.
- Results publication: PubMed 36110490Gunasekaran A, Govindaraj K, Gupta SL, Vinayagam S, Mishra SK. Comparison of Gastric Insufflation Volume Between Ambu AuraGain and ProSeal Laryngeal Mask Airway Using Ultrasonography in Patients Undergoing General Anesthesia: A Randomized Controlled Trial. Cureus. 2022 Aug 11;14(8):e27888. doi: 10.7759/cureus.27888. eCollection 2022 Aug.
- Results publication: PubMed 30443057Sharma G, Jacob R, Mahankali S, Ravindra MN. Preoperative assessment of gastric contents and volume using bedside ultrasound in adult patients: A prospective, observational, correlation study. Indian J Anaesth. 2018 Oct;62(10):753-758. doi: 10.4103/ija.IJA_147_18.
- Results publication: PubMed 31435997Beck CE, Rudolp D, Becke-Jakob K, Schindler E, Etspuler A, Trapp A, Fink G, Muller-Lobeck L, Roher K, Genahr A, Eich C, Sumpelmann R. Real fasting times and incidence of pulmonary aspiration in children: Results of a German prospective multicenter observational study. Paediatr Anaesth. 2019 Oct;29(10):1040-1045. doi: 10.1111/pan.13725. Epub 2019 Sep 4.
- Results publication: PubMed 33096743Fiedler MO, Schatzle E, Contzen M, Gernoth C, Weiss C, Walter T, Viergutz T, Kalenka A. Evaluation of Different Positive End-Expiratory Pressures Using Supreme Airway Laryngeal Mask during Minor Surgical Procedures in Children. Medicina (Kaunas). 2020 Oct 21;56(10):551. doi: 10.3390/medicina56100551.
- 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 Pediatrics and Fasting Period, run by Duygu Akyol 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 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: finished, as of the sponsor's last update on 19 Sep 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?
Gastric residual volume (time frame: preoperatively, intraoperatively after laryngeal mask placement, before laryngeal mask removal at the end of surgery). 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 NCT06426394, which also lists 4 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 19 Sep 2025.