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RECRUITING
NCT07234188
NA

POM vs HFNC for Hypoxemia Prevention in Children

Sponsor: Bedirhan Günel

View on ClinicalTrials.gov

Summary

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.

Official title: Comparison of a Procedural Oxygen Mask and High-Flow Nasal Cannula for the Prevention of Hypoxemia During Pediatric Upper Gastrointestinal Endoscopy Under Sedation: A Single-Center Randomized Controlled Pilot Trial

Key Details

Gender

All

Age Range

6 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-03-04

Completion Date

2026-05-31

Last Updated

2026-03-06

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Procedural Oxygen Mask

Delivers oxygen through the mouth and nose during sedation while allowing endoscope passage.

DEVICE

High-Flow Nasal Cannula

Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure.

Locations (1)

Kocaeli City Hospital

Kocaeli, Izmit, Turkey (Türkiye)