RecruitingNot ApplicableNCT07234188

POM vs HFNC for Hypoxemia Prevention in Children

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


Sponsor

Bedirhan Günel

Enrollment

30 participants

Start Date

Mar 4, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 16 Years

Inclusion Criteria5

  • Patients who consented to participate in the study
  • Aged between 6 and 16 years
  • Body weight \>30 kg
  • ASA physical status I-II
  • Children scheduled to undergo procedural sedation for non-emergency upper gastrointestinal endoscopy

Exclusion Criteria10

  • Lack of parental consent or refusal to sign the participant consent form
  • History of endotracheal intubation within the past 3 months
  • History of lower respiratory tract infection within the past 3 months
  • History of intensive care unit (ICU) admission within the past 3 months
  • Presence of a tracheostomy
  • History of tracheostomy placement
  • Patients with oxygen dependency due to any underlying disease
  • Known pulmonary or cardiac disease
  • Known congenital craniofacial anomalies
  • Congenital or acquired upper airway malformations

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Interventions

DEVICEProcedural Oxygen Mask

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

DEVICEHigh-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)

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NCT07234188


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