CompletedNot Applicable

POM vs HFNC for Hypoxemia Prevention in Children

Turkey (Türkiye)30 participantsStarted 2026-03-04

Plain-language 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.

Who can participate

Age range

6 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lowest SpO₂ level during procedure

Timeframe: From the start of sedation to end of endoscopy (typically 5-20 minutes)

Trial details

NCT IDNCT07234188

SponsorBedirhan Günel

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-05-21

View on ClinicalTrials.gov More Hypoxemia trials