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Upper gastrointestinal endoscopy is a commonly performed diagnostic and therapeutic procedure in children, allowing evaluation of the esophagus, stomach, and duodenum, as well as interventions such as biopsy, foreign body removal, and polypectomy. Sedation is routinely used, often at greater depths than for standard examinations. Due to anatomical and physiological differences, including smaller airway diameter, higher oxygen consumption, and lower functional residual capacity, pediatric patients are at higher risk of airway obstruction, hypoxemia, and hypoventilation compared to adults. The passage of the endoscope through the mouth further limits airway access and increases the risk of desaturation. Oxygenation during pediatric endoscopy is typically supported using nasal cannulas, high-flow systems, or procedural oxygen masks (POM™). This pilot randomized study aims to compare POM™ and high-flow nasal cannula in preventing hypoxemia during sedated pediatric upper gastrointestinal endoscopy, contributing evidence for safer sedation and airway management practices in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group P | Experimental | Oxygen delivered via Procedural Oxygen Mask (POM™) at a fixed flow of 15 L/min (approx. FiO₂ 95%) throughout the procedure. |
|
| Group H | Active Comparator | Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedural Oxygen Mask | Device | Delivers oxygen through the mouth and nose during sedation while allowing endoscope passage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lowest SpO₂ level during procedure | The lowest peripheral oxygen saturation (SpO₂) recorded between the initiation of sedation and the removal of the gastroscope was defined as the primary outcome. It was measured via continuous pulse oximetry, and when SpO₂ fluctuated, the value maintained for more than 10 seconds was recorded. | From the start of sedation to end of endoscopy (typically 5-20 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypoxemia | Defined as any drop in SpO₂ <94% lasting for at least 10 seconds. Based on pulse oximetry recordings. | During endoscopic procedure (from sedation start to endoscope removal) |
| Number of hypoxemic episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bedirhan Günel, MD | Kocaeli City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli City Hospital | Kocaeli | Izmit | 41100 | Turkey (Türkiye) |
Data will be shared upon reasonable request.
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| High-Flow Nasal Cannula | Device | Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure. |
|
Recurrent desaturations: counted when SpO₂ falls <94% again, at least 30 seconds after a return to ≥94%.
| During endoscopic procedure |
| Duration of hypoxemia (in seconds) | Time required for SpO₂ to return to ≥94% after each episode of desaturation (<94%). | During endoscopic procedure |
| Airway interventions | Number of occurrences requiring airway maneuvers (chin lift, jaw thrust, or mask ventilation). | During endoscopic procedure |
| Hemodynamic complications | Incidence of hypotension (>20% drop from baseline systolic BP), hypertension (>20% increase), bradycardia or tachycardia per age-specific thresholds. | During endoscopic procedure |
| Gastroenterologist satisfaction score | Rated from 0 (poor sedation, interrupted) to 10 (optimal sedation). | During endoscopic procedure |
| Incidence of Device Repositioning | Adjustment of POM™ or HFNC due to displacement, leakage, or malfunction. | During endoscopic procedure |