Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between duration of surgery and change in gastric volume | Total duration of the surgical procedure and the change in gastric volume | 30 minutes to 2 hours |
| Antral cross sectional area changes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Pediatric patients (1-10 years) undergoing elective surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meltem Savran Karadeniz, Professor | Contact | +9005334845563 | mskaradeniz@gmail.com | |
| Zeynep Sandikci, Resident | Contact | +905396076093 | zeynepsandikcii@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Meltem Savran Karadeniz | Istanbul University Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36960139 | Background | 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. | |
| 22956643 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Meauserement of antral cross sectional area at T0, T1 and T2 on lateral decubitis position
| up to 2 hours |
| Air leakege | Air leakage percentage with different airway devices | up to 2 hours |
| Airway pressures | Peak airway pressures during surgery duration | up to 2 hours |
| SpO2 | Pulse oximeter | up to 2 hours |
| Heart rate | ECG monitoring | up to 2 hours |
| Mean arteryal pressure | Non-invasive blood pressure measurement | up to 2 hours |
| Airway complications | Perioperative airway complications such as bronchospasm, laryngospasm etc. will be noted | up to 3 hours |
| 26239668 | Background | 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. |