Comparison of Gastric Volume Changes After Ventilation With Endotracheal Tube, First-Generation Supraglottic Airway, and Second-Generation Supraglottic Airway in Pediatric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gastric Ultrasonography, Supraglottic Airways, Supraglottic Airway Use in Children, Gastric Volume. Basic parameters: 1 year — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Comparison of gastric volume changes smong study groups [Time frame: up to 2 hours]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- 1-10 years of age
- Adherence to standard preoperative fasting guidelines
- Elective surgeries
- ASA I-III status
- Surgery time 30 min to 2 hours
Exclusion criteria
- Gastrointestinal tract surgeries
- Laparoscopic surgeries
- Emergency procedures
- Full stomach patients
- Lack of parental/guardian consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Istanbul University — Istanbul
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. PMID 36960139
- Theiler 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. PMID 22956643
- Alakkad 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. PMID 26239668
Identifiers
NCT: NCT07555080 · 2025/437